FDA 510(k) Glossary · regulatory

K-Number

A K-number is the unique identifier assigned by the FDA to each 510(k) premarket notification submission, formatted as the letter K followed by a 2-digit year and a 4-digit sequential number (e.g., K243854). The K-number serves as the permanent reference for a 510(k) clearance in FDA records, regulatory filings, and the 510k Database.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
166,200+ K-numbers indexed in the 510k Database dataset, from K760001 (1976) to the most recent clearances. Each K-number has a dedicated device record page.

Definition

A K-number is the unique alphanumeric identifier assigned by the FDA to every 510(k) premarket notification submission. It follows the format:

K [YY] [NNNN] - e.g., K 24 3854

Where YY is the 2-digit year of submission and NNNN is the sequential submission number for that year.

K-Number in the Regulatory Record

The K-number appears in:

  • The FDA's 510(k) clearance letter sent to the manufacturer
  • The FDA's public accessdata.fda.gov database
  • Device labeling (as evidence of clearance)
  • Regulatory submissions citing the device as a predicate device
  • The 510k Database, where each K-number has its own dedicated URL

Dataset Insights

MetricValue
Total K-numbers in dataset166,200+
Earliest K-numberK760001 (1976)
K-numbers with clinical trial link188
K-numbers with PCCP authorization91
K-numbers with consultant identified11,050

Search any K-number in the 510k Database

Related Terms

510(k) Premarket Notification - 510(k) Clearance - Predicate Device - Product Code

Frequently Asked Questions

A K-number is the unique identifier assigned to every 510(k) premarket notification submission. It follows the format K + 2-digit year + 4-digit sequential number. For example, K243854 is the 3,854th submission of 2024. The K-number appears on the device's 510(k) clearance letter and serves as the permanent reference in FDA records and on the device's labeling.

K-numbers are searchable on FDA's accessdata.fda.gov 510(k) database. The 510k Database allows direct lookup by K-number - enter the full K-number (e.g., K243854) in the search field to retrieve the device record, including manufacturer, product code, decision date, review time, and enriched regulatory intelligence data.

The 510k Database tracks 166,200+ submissions from K760001 (1976) through the most recent clearances. The first K-numbers in 1976 started at K760001. In recent years, the FDA processes approximately 3,000-4,000 510(k) submissions annually, meaning K-numbers now reach into the 3,000-4,000 range per year.

Yes. Each 510(k) submission receives its own unique K-number, regardless of the manufacturer. A large manufacturer like Abbott Laboratories may have hundreds of K-numbers across different devices and submission years. The 510k Database groups K-numbers by manufacturer to show the full regulatory history of each company.