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 |
|---|---|---|---|---|---|
| K010318 | Prima Oxygen Monitor | Penlon, Ltd. | CCL | Class II | |
| K010317 | Av 800 Ventilator | Penlon, Ltd. | CBK | Class II | |
| K003805 | Gynecological Laparoscopes | Global Endoscopy, Inc. | HET | Class II | |
| K003802 | Hysteroscopes | Global Endoscopy, Inc. | HIH | Class II | |
| K983332 | Northeast Proton Therapy Center | Massachusetts General Hospital | LHN | Class II | |
| K012194 | Blood Pressure Monitor (Sphygmomanometer), Model Ht-110 | Nihon Seimitsu Sokki Co., Ltd. | DXQ | Class II | |
| K012133 | Livesure Barbiturates Screen Test | Pan Probe Biotech, Inc. | DIS | Class II | |
| K012131 | Livesure Benzodiazepines Screen Tests | Pan Probe Biotech, Inc. | JXM | Class II | |
| K012107 | Livesure Phenecycline (Pcp) Screen Tests | Pan Probe Biotech, Inc. | LCM | Unclassified | |
| K012094 | Modification to Device Link System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K012027 | Modification to Xia Spine System | Howmedica Osteonics Corp | MNH | Class II | |
| K012019 | Color Buffed (Cb) Ddh Femoral Stem | Zimmer GmbH | JDI | Class II | |
| K012016 | Infinity Sc 8000 with Advanced Communication Option II | Siemens Medical Solutions USA, Inc. | MHX | Class II | |
| K011874 | Fadasis Medical Fm-1 No Blender | Fadasis Medical, Inc. | MRO | Class II | |
| K011599 | Alkaline Phosphatase Liquid Reagent | JAS Diagnostics/Drew Scientific | CJE | Class II | |
| K011539 | Rossmax Medipro Model 100, Model 200, and Model 300 Blood Pressure Monitors | Rossmax International Ltd. | DXN | Class II | |
| K011352 | Rossmax Smartinflate Cardiopro, Model 1000I and Model 3000I Blood Pressure Monitors | Rossmax International Ltd. | DXN | Class II | |
| K011345 | Cardionavigator Information Management System | Reynolds Medical, Ltd. | DXH | Class II | |
| K011319 | Stryker Titanium Cross-Screw System, Model 234-500-1Xx | Stryker Corp. | JDW | Class II | |
| K011310 | Nien Made Non-Invasive Blood Pressure Monitor, Models Hp-Bpm0001; Hp-Bpm0002; Hp-Bpm0003; Hp-Bpm0003-1 | Nien Made Electrnics Corp. | DXN | Class II | |
| K011253 | Flavored Male Latex Condom | Thai Nippon Rubber Industry Co., Ltd. | HIS | Class II | |
| K011235 | Sysmex Automated Coagulation Analyzer / Model # Ca-1500 | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K011118 | Normed Extremity Titanium Hand and Small Fragment System | Osteomedics, Inc. | HRS | Class II | |
| K010911 | Macropore Os Spinal System | Macropore Biosurgery, Inc. | KWQ | Class II | |
| K003851 | Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model Bc-1119 | BioCheck Inc | DCK | Class II | |
| K003831 | Arthroscopes | Global Endoscopy, Inc. | HRX | Class II | |
| K012061 | Superior Bath, Model 6300 | Penner Manufacturing, Inc. | ILJ | Class II | |
| K012057 | Cascade Bath, Model 6900 | Penner Manufacturing, Inc. | ILJ | Class II | |
| K011969 | Synthes Cervifix System | Synthes (USA) Products LLC | KWP | Class II | |
| K011904 | Nexgen Primary Porous Patella, Model 04-211-Iiii-5878-65-Zz-(Standard),04-212-Iiii-5878-61-Zz-(Micro) | Implex Corp. | JWH | Class II | |
| K011549 | Ohmeda Medical Spot Pt Lite Phototherapy System | GE Healthcare | LBI | Class II | |
| K011501 | Endopouch Retriever | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K011452 | Cavex Stabisil | Cavex Holland B.V. | ELW | Class II | |
| K011360 | Mtp Laparomat Disposable Tubing Set | Mtp Medical Technical Promotion GmbH | GCJ | Class II | |
| K011296 | Infinion Enhancement Package | Philips North America LLC | LNH | Class II | |
| K011279 | Entec Evac Plasma Wand | ArthroCare Corporation | GEI | Class II | |
| K004025 | Splittable Sheath Introducer Kit | Merit Medical Systems, Inc. | DYB | Class II | |
| K004003 | Pro Osteon 200R with Calcium Sulfate, Models 2Rcs038, 2Rcs050, 2Rcs075, 2Rcs10, 2Rcs15, 2Rcs20, 2Rcs225, 2Rcs30 | Interpore Cross Intl. | MQV | Class II | |
| K012026 | Trident All Poly Cup | Howmedica Osteonics Corp | JDI | Class II | |
| K012001 | Smartscrew | Bionx Implants, Inc. | HWC | Class II | |
| K012000 | 1.5Mm Bone Fixation Kit | Bionx Implants, Inc. | HWC | Class II | |
| K011957 | Ivent 201 Portable Ventilator | Versamed, Ltd. | CBK | Class II | |
| K011938 | Oil for Embryo Culture | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K011881 | Dynalink .035 Biliary Self-Expanding Stent System | Boston Scientific Corporation | FGE | Class II | |
| K011756 | Admira Flow | Voco GmbH | EBF | Class II | |
| K011552 | Urological Catheter | Robling Medical, LLC | GBM | Class II | |
| K011455 | Biomet Oncology Salvage System (Oss) Taper Stacking Adapter | Zimmer GmbH | JDI | Class II | |
| K011312 | Blks-303 Mk Monoplace Hyperbaric System | Khrunichev State Research & Production Space Centr | CBF | Class II | |
| K011216 | PVC Free Intravascular Administration Set | Biometrix Ltd. | FPA | Class II | |
| K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion Needles | Parallax Medical, Inc. | KNW | Class II |