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 |
|---|---|---|---|---|---|
| K971816 | Atlas Fracture Proximal Humeral Nail | Zimmer GmbH | HSB | Class II | |
| K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (USA) Products LLC | HTY | Class II | |
| K971743 | Sharplan CO2 Surgical Laser System | Sharplan Lasers, Inc. | GEX | Class II | |
| K971598 | Sterichek Chlorine Reagent Strips | Environmental Test Systems, Inc. | MSY | Class II | |
| K971581 | Hemisphere Cemented Cup | Ortho Development Corp. | JDI | Class II | |
| K971579 | Cordis Opta 5 Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K971568 | Rest Mattress | Rest Mattress | FNM | Class II | |
| K971481 | Duralastic Anatomical Nasal Implants | Allied Biomedical Corp. | FZE | Class II | |
| K971479 | Duralastic Anatomical Malar Implants | Allied Biomedical Corp. | LZK | Class II | |
| K971478 | Duralastic Anatomical Chin Implants | Allied Biomedical Corp. | FWP | Class II | |
| K971459 | Dermalase | Endo Technic Corp. | GEX | Class II | |
| K971446 | 3M Universal Electrosurgical Pad Split/solid(9130&9160) | 3M Company | GEI | Class II | |
| K971310 | Aesculap Jet Irrigation System | Aesculap Inc | GEI | Class II | |
| K971227 | Cryo Check Factor X Deficient Plasma | Precision Biologicals, Inc. | GJT | Class II | |
| K971226 | Cryo Check Factor IX Deficient Plasma | Precision Biologicals, Inc. | GJT | Class II | |
| K970547 | Isolyser Sds Sharps Container | Thantex Specialties, Inc. | FMI | Class II | |
| K964036 | Cardiomagic 2000 Software | Instromedix, Inc. | DXH | Class II | |
| K963574 | Pulse*spray Injector | Boston Scientific Corporation | FRN | Class II | |
| K962159 | Sterile Ambulatory Reservoir 60Ml/100ml | Faulding Medical Device Co. | MRZ | Class II | |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | Sil-Med Corp. | FJS | Class II | |
| K954320 | Modified Pedikair | KCI USA, Inc. | FNM | Class II | |
| K972297 | Amylase-Incorporating Dynamic Stabilization Technology - (Dst) | Trace America, Inc. | JFJ | Class II | |
| K972155 | Creatine Kinase (Ck) | Stanbio Laboratory | CGS | Class II | |
| K971755 | Hoffmann II Compact External Fixation System | Howmedica Corp. | JEC | Class II | |
| K971450 | Somnoplasty System | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | MOI | Class II | |
| K971225 | Cryo Check Factor VIII Deficient Plasma | Precision Biologicals, Inc. | GJT | Class II | |
| K971224 | Cryo Check Factor VII Deficient Plasma | Precision Biologicals, Inc. | GJT | Class II | |
| K971189 | P.f.c. Sigma Knee System (Size 1.5) | Johnson & Johnson Professionals, Inc. | JWH | Class II | |
| K970471 | Mentor Ultrasound Assisted Tissue Removal System (Trs) | Mentor | LFL | Unclassified | |
| K965123 | Pace Saver, Little Junior (Modification)(motorized Three-Wheeled Vehicle) | Burke, Inc. | INI | Class II | |
| K961719 | Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses | Howmedica Leibinger, Inc. | HRS | Class II | |
| K972027 | Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials (Light Body/normal,light Body/fast Setting,regular Body,) | Zhermack S.p.A. | ELW | Class II | |
| K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | JDQ | Class II | |
| K971652 | P.f.c. Sigma Inset Patella | Johnson & Johnson Professionals, Inc. | JWH | Class II | |
| K971497 | Osteonics Anteverted Neck Hip Stem | Osteonics Corp. | LZO | Class II | |
| K971461 | Servo-Control Wall-Mount Infant Warmer(iw980)/manual-Control Wall-Mount Infant Warmer(iw990) | Fisher & Paykel Electronics, Ltd. | FMT | Class II | |
| K971457 | Bryan Posterior Spinal Fixator (Bpsf), Modified | Arcan Orthopaedic Corp. | KWP | Class II | |
| K971416 | Olympus Oes Otv-S5c Video System | OLYMPUS Corporation of the Americas | FET | Class II | |
| K971414 | Zirconia Prozyr Ceramic 12/14 Global Taper (Gt) Femoral Heads | Smith & Nephew, Inc., Orthopaedic Div. | LZO | Class II | |
| K970478 | Sct 3000 Heated Humidifier | Marquest Medical Products, Inc. | BTT | Class II | |
| K965172 | Oximeter Pre-Amp Cable | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K964821 | Coverox Sheath Models Number Ps65, Ps67, Eps65 and Eps67 | Ventrex, Inc. | DQA | Class II | |
| K964439 | Needle-Free Valved Connector and Cap | Bmw Medical, Inc. | FPA | Class II | |
| K972096 | Bivalve Nasal Splint | Boston Medical Products, Inc. | LYA | Class I | |
| K971647 | Ll Bi-Focal, Daily Wear Contact Lens | Lombart Lenses, Ltd. | LPL | Class II | |
| K971355 | Nihon Kohden Tec-7531 Cardiolife Portable Defibrillator and Accessories | Nihon Kohden America Inc | LDD | Class II | |
| K971168 | One-Day/five-Day/seven-Day Syringe Mate | Baxter Healthcare Corporation | MEB | Class II | |
| K971002 | Smile with Confidence | Lloyd V. Ziemendorf | EHS | Class II | |
| K970683 | Zentih Flowable Composite (Multiple) | Foremost Dental Mfg., Inc. | EBF | Class II |