The 510(k) premarket notification is the most common pathway to market for medical devices in the United States. Understanding 510(k) clearance trends — who is filing, what product categories dominate, and how review times are changing — provides critical market intelligence for device manufacturers, regulatory consultants, investors, and competitive analysts.

This analysis covers 510(k) clearance patterns across multiple dimensions using data from official FDA databases. All statistics referenced here are available for live exploration on our 510(k) clearance statistics dashboard, which updates daily from FDA source data.

1. What Is a 510(k) Clearance?

A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is "substantially equivalent" to a legally marketed device (the predicate). It is not an "approval" in the formal sense — that term applies to PMA (Premarket Approval) devices — but rather a clearance that allows the device to be marketed in the United States.

The 510(k) pathway is significant because it covers the vast majority of medical devices entering the US market. There are three types:

510(k) Type Description Typical Review Time
Traditional Standard submission with full comparison to predicate device 3–6 months
Special For modifications to a manufacturer's own cleared device; streamlined review 30–60 days
Abbreviated Relies on FDA-recognized guidance, standards, or special controls 2–4 months

Important distinction: A 510(k) "clearance" means the FDA found the device substantially equivalent to a predicate. It does not mean the FDA has independently validated the device's safety and effectiveness, as in the PMA process. This distinction is frequently misunderstood in media coverage.

The FDA processes thousands of 510(k) submissions annually. Historical volume shows both consistency and meaningful shifts driven by regulatory policy, industry dynamics, and technology trends.

Key volume observations

  • Steady baseline: The FDA typically clears 3,000–3,500 510(k) submissions per year, a number that has been relatively stable over the past decade.
  • Submission vs. clearance counts: Not every submission results in clearance. A meaningful percentage receive "Not Substantially Equivalent" (NSE) decisions or are withdrawn before a decision is reached.
  • COVID-era bump: The 2020–2021 period saw an increase in 510(k) submissions for diagnostic tests, respiratory devices, and PPE. Many of these were novel entrants to the device market, some of which later failed to maintain quality standards.
  • Post-pandemic normalization: 2023–2025 volumes have returned to pre-pandemic patterns, with growth concentrated in software-as-a-medical-device (SaMD) and AI/ML-enabled diagnostics.

You can explore year-by-year 510(k) clearance volumes on our live statistics dashboard, which includes interactive charts with filtering by company, product code, and decision type.

3. Decision Codes: SE, SK, and Beyond

Every 510(k) submission results in one of several decision codes. Understanding these codes is essential for interpreting clearance data correctly.

Code Meaning Implication
SESE Substantially Equivalent Cleared to market — the most common outcome
SESD Substantially Equivalent with conditions Cleared with specific labeling or post-market requirements
SKNF Substantially Equivalent per Notification Cleared under special 510(k) pathway
SNSE Not Substantially Equivalent Rejected — device must pursue de novo or PMA pathway
SKWN Withdrawn Applicant withdrew before FDA decision

The clearance rate (SESE + SESD outcomes as a percentage of all submissions) has historically been around 85–90%, though this varies by product category. Categories with well-established predicates and clear guidance documents tend to have higher clearance rates.

4. Average Review Times

Review time — the duration from submission date to decision date — is one of the most closely watched metrics in the medical device industry. It directly impacts product launch timelines and competitive positioning.

Factors affecting review time

  • Product novelty: Devices that are clearly similar to well-established predicates move through review faster than those pushing into new territory.
  • Submission quality: Incomplete submissions trigger Additional Information (AI) requests, which can add months to the review timeline. First-time submitters are more likely to receive AI requests.
  • FDA center workload: CDRH review capacity fluctuates with staffing and budget. User fee programs (MDUFA) have helped stabilize review timelines by providing dedicated funding.
  • Product code complexity: Some product categories — particularly combination products, software devices, and novel technologies — consistently require longer reviews.
  • Special 510(k): The special pathway is significantly faster, typically 30–60 days, making it attractive for iterative device improvements.

Our 510(k) statistics dashboard shows average review time broken down by product code, company, and year — so you can benchmark your expected timeline against real data.

5. Top Companies by 510(k) Volume

The 510(k) landscape is dominated by a mix of large established manufacturers and specialized device companies. The top submitters by volume tend to be companies with broad device portfolios that regularly iterate on existing products.

Patterns in company-level data

  • Diversified device manufacturers like Medtronic, Abbott, Becton Dickinson, Siemens Healthineers, and GE HealthCare consistently file the most 510(k) submissions, reflecting their large product lines and ongoing product updates.
  • IVD (in vitro diagnostics) companies are among the most active submitters, as diagnostic tests frequently require new or updated clearances.
  • Emerging digital health companies have become increasingly visible in 510(k) filings, particularly for software-based devices and AI/ML-enabled tools.
  • International manufacturers: A growing share of 510(k) submissions come from non-US companies, particularly from Germany, Japan, South Korea, and China, reflecting the global nature of the medical device market.

As with our recall trend analysis, company name normalization is critical for accurate 510(k) counting. FDA Data MCP resolves subsidiary names, trade names, and name variations so you can see filing volume at the parent company level. Learn more about our normalization approach.

6. Product Code Trends

Every 510(k) clearance is associated with a three-letter FDA product code that identifies the device type. Analyzing product code trends reveals which device categories are growing, shrinking, or emerging.

High-volume product codes

Product Code Device Category Trend
QAS Clinical chemistry analyzer Stable
DXN Absorbable surgical suture Stable
OEI Software (AI/ML diagnostic) Strong growth
FRN Orthopedic implant Moderate growth
QKQ COVID-19 diagnostic test Declining (post-pandemic)
DSY Endoscope accessories Stable

The most notable trend is the rapid growth of software-based product codes. AI/ML-enabled devices, SaMD, and digital health tools have gone from a niche category to one of the fastest-growing segments in 510(k) filings.

7. Traditional vs. Special 510(k)

The choice between traditional and special 510(k) pathways has strategic implications for device companies. Understanding the usage patterns helps regulatory teams make informed filing decisions.

Traditional 510(k)

The traditional pathway is used for new devices or modifications that involve a new intended use, different technology, or a change to the predicate device. It requires:

  • Detailed device description and comparison to predicate
  • Performance testing data (bench, animal, clinical as appropriate)
  • Biocompatibility data (if applicable)
  • Software documentation (for software-driven devices)

Special 510(k)

The special pathway is available when a manufacturer modifies its own legally marketed device and the change does not affect the intended use or alter the fundamental scientific technology. It relies heavily on the manufacturer's design controls and risk analysis rather than independent testing.

Advantages of the special pathway include:

  • Significantly shorter review time (30–60 days vs. 3–6 months)
  • Lower documentation burden
  • More predictable outcomes for iterative improvements

The adoption of the special 510(k) pathway has grown steadily as companies optimize their regulatory strategies and invest in design control infrastructure that supports this approach.

8. AI/ML-Enabled Device Clearances

One of the most significant trends in recent 510(k) data is the growth of AI/ML-enabled medical device clearances. The FDA maintains a public list of authorized AI/ML devices, and the rate of new clearances has accelerated dramatically.

Key patterns in AI/ML device clearances

  • Radiology dominance: The majority of AI/ML clearances are for radiology applications — computer-aided detection, image analysis, triage, and workflow optimization.
  • Cardiology growth: AI-enabled ECG interpretation and cardiac monitoring have emerged as a significant category.
  • Pathology and dermatology: Newer entrants using AI for pathology slide analysis and dermatological screening are growing rapidly.
  • Predicate chains: Many AI/ML 510(k) submissions reference other AI/ML devices as predicates, creating a self-reinforcing pathway that accelerates future clearances.
  • Predetermined change control plans: The FDA's evolving framework for AI/ML devices that learn and adapt post-market is creating new regulatory categories that don't fit neatly into the traditional 510(k) framework.

Tracking AI/ML device clearances through 510(k) data is essential for competitive intelligence in the digital health space. Our 510(k) statistics page allows filtering by product code to isolate AI/ML-related clearances.

9. Accessing 510(k) Data Programmatically

All the 510(k) data analyzed in this article is available through FDA Data MCP as structured, queryable data. Whether you're building competitive intelligence tools, tracking specific product categories, or analyzing a company's regulatory portfolio, the API provides comprehensive access.

Example: Search 510(k) clearances for a company

{
  "tool": "fda_search_510k",
  "args": {
    "company": "Siemens",
    "year_from": 2023,
    "limit": 50
  }
}

Example: Look up a specific 510(k) by number

{
  "tool": "fda_get_510k",
  "args": {
    "k_number": "K231234"
  }
}

Example: Find clearances by product code

{
  "tool": "fda_search_510k",
  "args": {
    "product_code": "QAS",
    "decision_code": "SESE",
    "year_from": 2024
  }
}

The API returns structured JSON with full clearance details — K number, applicant, decision date, decision code, product code, device name, statement of substantial equivalence, and more. You can filter by company, product code, decision code, date range, and review type.

For the full tool reference and integration guides for Claude, Cursor, Windsurf, and other MCP clients, see the documentation.

Access 510(k) Data Programmatically

Query 510(k) clearances, track competitors, and analyze product code trends through FDA Data MCP. Connect your AI agent and start exploring device approval data in seconds.

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Further Reading