Bringing a medical device to the U.S. market is rarely simple. Teams face a maze of regulatory pathways, and for new teams working on their first development cycle, the 510(k) submission process can be a minefield.
You probably have a lot of questions, like:
- What does the FDA expect?
- How long will it take?
- What documents are required?
- How much will it cost?
This FAQ is designed to answer the eight questions regulatory leaders most often ask about 510(k) submissions. Each answer ties practical advice to the real-world challenges that companies face and highlights how better documentation management can prevent the delays and costs that often derail a clearance strategy.
What is a 510(k) submission and when is it required?
A 510(k) submission is the most common pathway medical device companies use to bring a product to the U.S. market. It’s the FDA’s way of determining whether your device is “substantially equivalent” to another device that’s already legally marketed, called a predicate device.
You’re required to submit a 510(k) if you plan to market a Class II device, or in some cases a Class I device, that hasn’t been exempted. If you’re introducing a device that has the same intended use as an existing product but uses different technology, you’ll need to prove that those differences don’t raise new safety or effectiveness concerns.
The confusion often comes from knowing which regulatory path applies. Should you file a 510(k), go through the De Novo process, or prepare for a full Premarket Approval (PMA)? The answer depends on how your device is classified and what risks it poses to patients.
Many companies trip up here because they rely on outdated spreadsheets or scattered SharePoint folders to track regulatory history and classification research. With a regulatory content management system like Kivo, teams can centralize past submissions, reference documents, and decision rationales in one place. That way, when leadership asks, “Do we need a 510(k)?” you can answer with documented confidence instead of guesswork.
What are the main steps in preparing a 510(k) submission?
The FDA process looks straightforward on paper, but teams often underestimate the planning and coordination it takes to get a complete 510(k) package ready. At a high level, here are the key steps:
-
Confirm device classification: Verify whether your product requires a 510(k), and if so, under what regulation number.
-
Select a predicate device: Identify a legally marketed device that your product can claim substantial equivalence to.
-
Plan and execute testing: Conduct bench, biocompatibility, electrical safety, or clinical testing as needed to demonstrate safety and performance.
-
Compile documentation: Prepare the submission package, which includes device description, intended use, performance testing results, labeling, and risk analysis.
-
Submit to FDA: Send the electronic submission through the FDA’s eSTAR template or equivalent system.
-
Respond to deficiencies: Address any FDA requests for additional information during review.
Each of these steps comes with its own challenges. Teams often find that gathering test data and aligning it with the correct version of documentation can consume weeks. If documents live in different systems or versions circulate without control, it’s easy for errors to slip into the final package.
That’s where a single source of truth helps. By powering quality, regulatory, and clinical from the same document management system, Kivo eliminates the back-and-forth between systems, linking testing data, SOPs, and submission-ready documents in one compliant platform. Instead of wasting energy chasing down files, regulatory leaders can focus on strategic decisions, like whether the chosen predicate really sets them up for the fastest approval path.
How long does the 510(k) review process take?
The FDA sets a target review timeline of 90 days for 510(k) submissions. In practice, many reviews take longer.
It’s common for the agency to issue a request for additional information (AI letter), which pauses the clock until you respond. If your submission isn’t complete or clearly documented, those pauses can stretch the timeline by months.
Most companies want predictability, but the reality is that review times vary widely depending on the device, the quality of your submission, and FDA workload. Some 510(k)s clear in as little as three months, while others extend past six months when deficiencies pile up.
For growing life sciences teams, the real challenge is aligning regulatory timelines with business milestones. Launch plans, investor updates, and clinical adoption often hinge on that clearance date. If the review process drags out because of missing documents or unclear test data, the business impact can be significant.
That’s why disciplined documentation management is essential. With Kivo, teams can track every testing report, regulatory justification, and version history in one place. When the FDA comes back with questions, you can respond quickly with validated documents instead of scrambling across shared drives. That speed doesn’t just cut review delays, it helps protect your launch plan from slipping.
What are the most common reasons the FDA rejects or delays 510(k) submissions?
Even experienced teams run into issues during 510(k) review. The FDA doesn’t reject submissions arbitrarily. There are consistent patterns in what causes delays or requests for additional information. The most common reasons include:
-
Incomplete testing data: Submitting bench or biocompatibility studies without full reports or clear methodologies.
-
Weak predicate justification: Choosing a predicate device that isn’t truly comparable in intended use or technology.
-
Poor document organization: Missing sections, mislabeled attachments, or conflicting information between different parts of the submission.
-
Unclear labeling or indications for use: Labeling that doesn’t align with the substantial equivalence claim.
-
Inconsistent risk analysis: Gaps between identified risks, testing performed, and mitigations described.
Each of these issues leads to the same outcome: FDA sends back an additional information request, and the review clock stops. The result is wasted time, added cost, and pressure on commercial plans.
For companies still relying on spreadsheets and file shares, these mistakes are almost inevitable. Different teams often use different document versions, or critical test reports get buried in email threads.
With Kivo, everything ties back to a single validated information management system. Predicate rationale, testing evidence, and labeling can all be linked in one controlled package, which reduces the chance of gaps and strengthens your position with FDA reviewers.
What documentation is required for a successful 510(k) submission?
A 510(k) is ultimately a documentation exercise. The FDA wants proof that your device is safe, effective, and substantially equivalent to a predicate. To do that, your submission must include a wide range of supporting materials.
The core components typically include:
-
Cover letter and administrative information
-
Device description: Design, materials, and technological characteristics
-
Indications for use: What the device is intended to do and in which patient population
-
Predicate comparison: A side-by-side summary showing how your device matches or differs from the predicate
-
Performance testing: Bench data, biocompatibility testing, electrical safety, software validation, and in some cases clinical evidence
-
Risk analysis: Documented hazards and mitigations
-
Labeling and instructions for use
-
Quality system information: Proof that you’re following design control and document control practices under 21 CFR Part 820
The challenge is assembling everything into a cohesive, consistent package. Missing a single performance report or submitting an outdated labeling file can derail months of work.
That’s why many regulatory teams move toward structured content systems. With Kivo, every document in the 510(k) package is version-controlled and linked back to its source. When your quality team updates a risk analysis or your clinical group finalizes a test report, the submission package updates automatically. That makes it easier to prove traceability and reduces the risk of last-minute errors.
What is a predicate device and how do I choose the right one?
A predicate device is the cornerstone of a 510(k) submission. It’s the legally marketed device you use to demonstrate that your product is “substantially equivalent” in terms of intended use and technological characteristics. The FDA reviews your device against this predicate to decide whether it can be cleared for market.
Choosing the right predicate is often more complex than it seems. A strong predicate should:
-
Have the same intended use as your device
-
Be classified under the same regulation number
-
Use similar technology or materials, or if different, not introduce new safety concerns
-
Have a clear, traceable history of FDA clearance
The wrong choice can lead to major setbacks. If the FDA decides your predicate doesn’t truly apply, your submission may be delayed or even redirected to the De Novo or PMA pathway, which adds significant time and cost.
This is where disciplined research and documentation pay off. Teams need access to past FDA clearances, product codes, and supporting data, and they need a way to keep that rationale accessible for audits or future submissions.
With Kivo, regulatory leaders can store predicate analysis and clearance histories in the same system they use for submission preparation. That way, future team members aren’t left guessing why a certain predicate was chosen. The full decision-making process is documented and inspection-ready.
What is the cost of a 510(k) submission?
The FDA charges a standard user fee for 510(k) submissions each fiscal year. For FY2025, the fee is $25,952 for standard applicants and $6,488 for small businesses that qualify for reduced rates. That’s just the baseline.
The real costs come from the work required to prepare a complete submission. Companies often spend far more on:
-
Testing: Bench, biocompatibility, electrical safety, and sometimes clinical studies. These can add tens or even hundreds of thousands of dollars.
-
Consultants: Many startups bring in regulatory experts to guide strategy or even draft sections of the 510(k).
-
Internal resources: Staff hours dedicated to writing, reviewing, and organizing documentation.
-
Quality system readiness: FDA expects compliant design controls and document management, which may require investment in systems and SOPs before filing.
For smaller companies, these costs can feel unpredictable. One missing test or poorly chosen predicate can trigger new expenses and weeks of delay.
That’s why a structured regulatory submission process matters. With Kivo, teams can build their submission package inside the same compliant document system they use for SOPs and quality records. This reduces reliance on outside consultants for basic document preparation and helps avoid costly rework. The result is a more predictable path to clearance and a clearer picture of the total cost of getting to market.
Do I need clinical data for my 510(k) submission?
Not every 510(k) requires clinical data. In fact, most are cleared based on bench testing and non-clinical performance evidence. The FDA only expects clinical data when non-clinical testing cannot fully address safety or effectiveness questions.
Examples where clinical data may be required include:
-
Devices with new technology not previously used in the predicate
-
Devices with novel materials in contact with patients
-
Implants or life-supporting devices where bench data alone may not capture real-world risks
-
Cases where bench or animal testing raises unanswered safety questions
Determining whether clinical data is necessary can be one of the most strategic decisions in the 510(k) process. If you over-commit to clinical studies, you add cost and time. If you under-prepare, you risk the FDA rejecting your submission for lack of evidence.
This is why documentation strategy matters as much as scientific planning. With Kivo, regulatory teams can link bench results, biocompatibility reports, and clinical evidence into one controlled package. If FDA reviewers raise concerns, you can respond with clear, traceable documentation that shows why the data you submitted is sufficient. That makes it easier to defend your strategy and keep the submission on track.
Next Steps
510(k) submissions may be a standard FDA pathway, but they’re far from simple. Each step — from predicate selection to performance testing to FDA review — demands complete, consistent documentation. For many life sciences teams, the biggest barrier isn’t the science, it’s managing the paperwork in a way that satisfies regulators and keeps launch timelines intact.
Kivo was built to solve this exact challenge for medtech teams. By unifying regulatory, quality, and clinical content in one compliant system, Kivo gives teams a reliable foundation for submission readiness. Whether you’re preparing your first 510(k) or managing a portfolio of devices, you’ll have a single source of truth for every document, decision, and test result.
That means fewer delays, stronger submissions, and more predictable paths to market.
