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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K913480 | Wound Care Tray a | Catalina Biomedical Corp. | MCY | Class II | |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589 | Specialty Packaging Producs, Inc. | CAT | Class I | |
| K913399 | Qbc E-Z Prep | BD Becton Dickinson Vacutainer Systems Preanalytic | JKA | Class II | |
| K913383 | Oxygen Masks 81420, 81421, 81471 & 81461 | Specialty Packaging Producs, Inc. | BYG | Class I | |
| K913246 | Hybrid Fit Total Hip System | Kirschner Medical Corp. | JDI | Class II | |
| K913245 | Model 80 Hearing Aid Dispensing System | 3M Company | ESD | Class I | |
| K912894 | Axiom Total Knee System, A/p Curved Tibial Insert | Orthomet, Inc. | JWH | Class II | |
| K912636 | Annulus Valvulotome | Cardio Source | MGZ | Class II | |
| K912635 | Annulus Disposable Valvulotome | Cardio Source | MGZ | Class II | |
| K912445 | Mega Continuous Epidural Anesthesia Kit | Mega Medical, Inc. | CAZ | Class II | |
| K912436 | Am-Pak | Cns, Inc. | GWL | Class II | |
| K912116 | Pressure Sore Management Kit | Medical Device Inspection Company | MCY | Class II | |
| K911465 | Infant/pediatric Resuscitation Circuit W/apl | Vital Signs, Inc. | BZD | Class II | |
| K911144 | Mf-500, Modification | Elcot, Inc. | QGH | Class II | |
| K910541 | Biokit Rpr | Biokit USA, Inc. | GMQ | Class II | |
| K914400 | Models E2502b/e2525 Reusable Handswitching Pencils | Medtronic, Inc. | GEI | Class II | |
| K914304 | First Response(r) One-Step | Armkel, LLC | LCX | Class II | |
| K914254 | Homeclinic One Step Pregnancy Test | Vanguard Biomedical Corp. | LCX | Class II | |
| K914130 | Auto Suture Titanium Skin and Fascia Staples | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K913836 | Vlc Glass Ionomer | Dentsply Intl. | EMA | Class II | |
| K913832 | Auto Suture(r) Powered Endoscopic Ta(r) Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K913802 | Auto Suture(r) Powered Endoscopic Gia(tm) Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K913761 | 3-D Accuscan Facial Implants | Implantech Associates Inc | FWP | Class II | |
| K913655 | Probase Hot and Probase Cold | Ivoclar North America, Inc. | EBI | Class II | |
| K913569 | Compac a, Elite a, Elite a Plus, Surgica a | Hgm Medical Laser Systems, Inc. | GEX | Class II | |
| K913288 | Medtronic Unipolar, Poly Pac Lead-Barr Coat Coils | Medtronic, Inc. | DTB | Class III | |
| K913271 | Osteo Bone Plated | Fred C. Bryson | HRS | Class II | |
| K913141 | Mega Myelogram Kit | Megadyne Medical Products, Inc | FMI | Class II | |
| K913083 | Bi-Temp Temperature Monitor Tm-201D | Respiratory Support Products, Inc. | FLL | Class II | |
| K913076 | i.v. Instant Timer | The Master Medical Corp. | FPA | Class II | |
| K913017 | Modulex Rtp System | Elekta Limited | KPQ | Class II | |
| K912590 | Avi Model 400D Infusion Pump | 3M Avi, Inc. | FRN | Class II | |
| K912589 | Avi Model 840D Dual Channel Infusion Pump | 3M Avi, Inc. | FRN | Class II | |
| K912280 | Bi-Temp Temperature Monitor, Model Tm-400D | Respiratory Support Products, Inc. | FLL | Class II | |
| K912144 | Simon Nitinol Filter, Modification | Nitinol Medical Technologies, Inc. | DTK | Class II | |
| K911650 | Pedia Pals | Pedia Pals, Inc. | ERA | Class I | |
| K911383 | Hotline Fluid Warmer | Level 1 Technologies, Inc. | LGZ | Class II | |
| K910693 | Pharmaseal Thoracentesis Tray W/univ Drainage Set | Baxter Healthcare Corporation | JOL | Class II | |
| K913801 | Cordis Cath Sheath Intro Syst Plus W/unistasis Val | Cordis US Corp. | DYB | Class II | |
| K913689 | Sub-4(Tm), Peripheral Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K913600 | Wristrecorder Cardiac Event Recording System | Ralin Laboratories, Inc. | DSH | Class II | |
| K913193 | Model 100 Central Station | Protocol Systems, Inc. | DQK | Class II | |
| K913191 | Dornier Laser Lithotripter Impact | Dornier Medtech America, Inc. | GEX | Class II | |
| K912621 | Model #911 Stealth Multi Pads | Cardiotronics, Inc. | LDD | Class II | |
| K912063 | Polaris, Oral Indication | Pfizer Laser Systems | GEX | Class II | |
| K911869 | Ivt Guiding Catheter | Intensive Technology, Inc. | DQY | Class II | |
| K911456 | Model #110 Stealth-Trode Child Defib Pads | Cardiotronics, Inc. | LDD | Class II | |
| K911455 | Model #100 Shock-Trode Child Defib Pads | Cardiotronics, Inc. | LDD | Class II | |
| K910884 | Card Guard, Models Cg-6000 & Cg-7000 | Card Guard Scientific Survival, Ltd. | DSH | Class II | |
| K905403 | Model 340 Series Unipolar & Model 5000B Programmer | Cook Pacemaker Corp. | DXY | Class III |