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 |
|---|---|---|---|---|---|
| K011302 | Randox Digoxin | Randox Laboratories, Limited | KXT | Class II | |
| K011199 | Proview Eye Pressure Monitor | Bausch & Lomb Incorporated | HKY | Class II | |
| K011171 | Tampax Scented & Satin Scented Tampax-Junior, Regular, Super & Super Plus | Procter & Gamble Co. | HIL | Class II | |
| K011110 | M2a Acetabular System | Zimmer GmbH | KWA | Class III | |
| K010599 | Protime Microcoagulation System / Protime 3 Cuvette | Accriva Diagnostics, Inc. | GJS | Class II | |
| K011711 | Modification to Ebi Efix Vision Fixation System | Ebi, LLC | KTT | Class II | |
| K011619 | Promax, Panoramic X-Ray Unit with Cephalostat | Planmeca Oy | EHD | Class II | |
| K011394 | Lava Frame, Lava Frame Shade, Lava Ceram | Espe Dental AG | EIH | Class II | |
| K011375 | Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture | Aesculap Inc | GAM | Class II | |
| K011000 | Tram 2001 Module | General Electric Medical Systems Information Techn | MHX | Class II | |
| K010692 | The Wand Plus Computer Controlled Anesthetic Delivery System | Spintech, Inc. | FMF | Class II | |
| K010311 | Lipomatic; Lipomatic Liposuction Device | Euromi S.A. | QPB | Class II | |
| K010139 | Zurich Distraction System | KLS-Martin L.P. | MQN | Class II | |
| K010029 | Home Health Monitoring System | Avid Care Corp. | DXN | Class II | |
| K011831 | Modification to Pleurx Pleural Catheter and Drainage Kits | Denver Biomedical, Inc. | DWM | Class II | |
| K011752 | Govan+ Wheelchair and Docking Accessory | Accufast, Inc. | IOR | Class I | |
| K011714 | BIPAP Pro Bi-Level System | Respironics, Inc. | BZD | Class II | |
| K011699 | Vacuette Evacuated Blood Collection Tubes | Greiner Bio-One Vacuette North America | JKA | Class II | |
| K011643 | Scorpio Cr Superflex Tibial Insert | Howmedica Osteonics Corp | JWH | Class II | |
| K011359 | Modification to Ksea Endotip System | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K011346 | Readyswim | Nidacon International AB | MQL | Class II | |
| K011317 | Multirate Infusor Sv; Multirate Infuser Lv; Baxter Pain Mate Pain Management System | Baxter Healthcare Corporation | MEB | Class II | |
| K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand | ArthroCare Corporation | HRX | Class II | |
| K011061 | Surgical Contra-Angel Handpieces Types Ws-56E,ws-75E/km,ws-92 E/3,surgical Straight Handpieces Types, S-9, S-10, S-11 | W & H DentalWerk Buermoos GmbH | EGS | Class I | |
| K011047 | Global Advantage Humeral Stem with Porocoat | Depuy Orthopaedics Inc. | MBF | Class II | |
| K010590 | Neuropack Micro, Model Med-9100A Series | Nihon Kohden America Inc | IKN | Class II | |
| K010422 | Act II Icp Monitoring System and Ventricular Catheter | Innerspace, Inc. | GWM | Class II | |
| K003999 | Aviva System, Model Sl 2020; Aviva Slx System System, Model Slx 1010 | American Telecare, Inc. | MWI | Class II | |
| K003759 | Aesculap Spiegelberg Brain Pressure Monitor | Aesculap Inc | GWM | Class II | |
| K003663 | Spacelabs Medical Anesthesia Delivery System (Ads) with Pressure Control Mode | GE Healthcare | BSZ | Class II | |
| K003180 | Hommed Observer, Model I | Hommed, LLC | DXN | Class II | |
| K002409 | Maxone, Blood, Blood Products and IV Fluid Warmer | Automatic Medical Technologies, Inc. | LGZ | Class II | |
| K011860 | Keyst0ne Medical Picc Catheter | Keystone Medical | FOZ | Class II | |
| K011704 | Npac Ear Thermometer Model Td 402 | Norm Pacific Automation Corp. | FLL | Class II | |
| K011697 | Ebi Xfix Access Pelvic Fixator | Ebi, LLC | KTT | Class II | |
| K011490 | Modification to Excite | Ivoclar North America, Inc. | KLE | Class II | |
| K011299 | Smith and Nephew 5.00Mm Absorbable Polymer Anchor | Smith & Nephew, Inc. | MAI | Class II | |
| K011295 | Restore-Pf Vic; Restore-Pf Vlc Capsule | First Scientific Limited | EBF | Class II | |
| K011180 | Ct/master, Version 1.0 | Columbia Scientific, Inc. | JAK | Class II | |
| K011075 | Easybell | Biopsybell S.A.S. | FCG | Class II | |
| K011034 | Synthes (USA) Medium External Fixation System | Synthes (USA) Products LLC | KTT | Class II | |
| K010998 | Langham Ocular Blood Flow (Obf) Tonograph/tonometer Model 201 | Langham Ophthalmic Technologies | HKX | Class II | |
| K010965 | A-Line Aep Monitor | CareFusion 303, Inc | OLW | Class II | |
| K010950 | Cypress System | Acuson Corp. | IYO | Class II | |
| K010943 | Synthes Sternal Fixation System | Synthes (USA) Products LLC | JDQ | Class II | |
| K010888 | Sideport Pinch Clamp Device | Medivice Systems, Ltd. | FPA | Class II | |
| K010745 | Ems 3000 | Dan Med, Inc. | IPF | Class II | |
| K003182 | Orthogenesis Lps System | Depuy, Inc. | JWH | Class II | |
| K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+motion Correction Performance | GE Healthcare | DQA | Class II | |
| K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2Ml, Model 580 | Bio-Rad | JJY | Class I |