510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K760086 | Tray, Blood Sampling (Pulsator II) | Concord Laboratories, Inc. | GJE | Class II | |
| K760082 | Bottle, Condensate (#1628) | Inspiron Corp. | CBC | Class II | |
| K760077 | Test, Ria, Serum Digoxin | Smithkline Diagnostics, Inc. | DND | Class II | |
| K760076 | Absorber, Anesthesia Circle Sys, CO2 | Fraser Sweatman, Inc. | BSF | Class I | |
| K760052 | Kit, Prep Shave | M-C Ind., Inc. | LDQ | ||
| K760041 | Filter, Respiratory (U-Mid) | BD Becton Dickinson Vacutainer Systems Preanalytic | CAH | Class II | |
| K760039 | Valve, I.m.v. (U-Mid One Way) | BD Becton Dickinson Vacutainer Systems Preanalytic | CBO | Class II | |
| K760037 | Heater, Immersion W/ Humidifier & Nebul. | Inspiron Corp. | BTT | Class II | |
| K760016 | Surgical Blades (Beaver) | Parke-Davis Co. | |||
| K760012 | Blood Warmer (Code 4R4305) | Travenol Laboratories, S.A. | BSB | Class II | |
| K760113 | Sponge, Laparotomy Gauze | Parke-Davis Co. | EFQ | Unclassified | |
| K760101 | Oxygen & Resuscitation (Hope II Model) | Ohio Medical Products | |||
| K760081 | Filter, Bacteria (#2290) | Inspiron Corp. | CAH | Class II | |
| K760080 | Cannula, Nasal, for Oxygen | Inspiron Corp. | CAT | Class I | |
| K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | FED | Class II | |
| K261609 | Freedom Partial Knee System | Maxx Orthopedics Inc. | HSX | Class II |