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 |
|---|---|---|---|---|---|
| K012158 | Modification to: Long Length Gamma Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K012135 | Powder Free Brown Latex Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K012128 | Protectiv Acuvance IV Catheter System | Ethicon Endo-Surgery Inc | FOZ | Class II | |
| K012090 | Cordis Palmaz Genesis Transhepatic Biliary Stent | Cordis, A Johnson & Johnson Co. | FGE | Class II | |
| K012087 | Cordis Palmaz Genesis Transhepatic Biliary Stent | Cordis US Corp. | FGE | Class II | |
| K012069 | Modification To:brevio Nerve Conduction Test Instrument | Neurotron Medical | JXE | Class II | |
| K012066 | Protege Self-Expanding Nitinol Stent with Starport Delivery Technology | Sulzer Intratherapeutics, Inc. | FGE | Class II | |
| K012059 | 8100/8500 Vital Signs Monitor | Criticare Systems, Inc. | MWI | Class II | |
| K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | FGE | Class II | |
| K011792 | Non-Chlorinated, Polymer Coated Powder-Free Nitrile Patient Examination Gloves | Latexx Partners Bhd. | LZA | Class I | |
| K011791 | Powder Free Nitrile Examination Gloves, Violet Color | Latexx Partners Bhd. | LZA | Class I | |
| K011521 | Ortho Vlc; Ortho Vlc Capsule | First Scientific Limited | DYH | Class II | |
| K011495 | Arthrex Bio-Post and Washer | Arthrex GmbH | MAI | Class II | |
| K011372 | Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical Suture | Aesculap Inc | GAM | Class II | |
| K011251 | Sparc Sling System | American Medical Systems, Inc. | OTN | Class II | |
| K010910 | Medicon Yasargil Clip Applying Forceps | Medicon, E.G. | HCI | Class II | |
| K010908 | Medicon Titanium Yasargil Aneurysm Clips | Medicon, E.G. | HCH | Class II | |
| K010738 | Cannulated Plus Screw System | Orthomatrix, Inc. | HWC | Class II | |
| K010500 | Automated Workcell Control Software | Lab-Interlink, Inc. | JJE | Class I | |
| K010454 | The Alberta Lens Sm2, Sulfocon B | Progressive Optical Research, Ltd. | HQD | Class II | |
| K010332 | Wako Immunoassay Calibrator Set | FUJIFILM Healthcare Americas Corporation | JIT | Class II | |
| K010300 | Medtronic Model 7495Lz Low Impedance Extension | Medtronic, Inc. | GZB | Class II | |
| K003839 | Central Venous Catheter | Boston Scientific Corporation | LJS | Class II | |
| DEN010002 | Given Diagnostic Imaging System | Given Imaging Ltd. | NEZ | Class II | |
| K012251 | Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes | Exactech, Inc. | JWH | Class II | |
| K012219 | Scalpfix Clip System | Aesculap Inc | HBO | Class II | |
| K012211 | Efilm Workstation | Efilm Medical, Inc. | LLZ | Class II | |
| K012175 | Pass Spinal System | Encore Orthopedics, Inc. | MNI | Class II | |
| K012099 | Monochrome Perfectly Flat Panel Displays, Me Series | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K011995 | Polymer Coated Latex Medical Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Quality Latex Products Malaysia Sdn Bhd | LYY | Class I | |
| K011900 | Glucose (Hexokinase) | JAS Diagnostics/Drew Scientific | CFR | Class II | |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature Option | ZOLL Medical Corporation | DSK | Class II | |
| K011685 | Bistite II Dc | Tokuyama America Inc. | EMA | Class II | |
| K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device | Acon Laboratories, Inc. | DKZ | Class II | |
| K011672 | Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test Device | Acon Laboratories, Inc. | LAF | Class II | |
| K011658 | Calibrator for Automated Systems (C.f.a.s.) Lipids | Rochdiag | JIX | Class II | |
| K011582 | Qcu Analytical Software Package | Medis Medical Imaging Systems, B.V. | LLZ | Class II | |
| K011522 | Resorbable Bone Pins | Zimmer GmbH | HTY | Class II | |
| K011489 | Summit Duofix Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K011354 | High Tibial Osteotomy Plating System | DJ Orthopedics, LLC | HRS | Class II | |
| K011131 | Methadone Microplate Eia Urine Application | Cozart Bioscience, Ltd. | DJR | Class II | |
| K010541 | Prevision Chem | Kulzer GmbH | EMA | Class II | |
| K010522 | Surevue Urine Hcg | SA Scientific, Ltd | JHI | Class II | |
| K010107 | R Stent Biliary Endoprosthesis | Orbusneich Medical, Inc. | FGE | Class II | |
| K003580 | Unitip Gastrointestinal Pressure Sensor Catheter | Unisensor AG | FFX | Class II | |
| K003285 | Exac Trac 2.0 (Novalis Body Module) | Brainlab, Inc. | IYE | Class II | |
| K001780 | Copan Viral Transystem | COPAN Diagnostics, Inc. | JSM | Class I | |
| K011663 | Minineph a-1 Antitrypsin Antiserum, High and Low Serum Controls | The Binding Site | DEM | Class II | |
| K011662 | Minineph a-1 Transferrin Antiserum, High and Low Serum Control | The Binding Site | DDG | Class II | |
| K011532 | Mityvac | Prism Enterprises, Inc. | HDB | Class II |