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 |
|---|---|---|---|---|---|
| K020715 | Philips M5066a and M5068a | Philips North America LLC | MKJ | Class III | |
| K011471 | Bilitec 2000, Polygram '98 Ph Testing Application (Incl.bile), Optical Fiber Prober | Medtronic Functional Diagnostics A/S | FFX | Class II | |
| K023631 | Astra Tech Dental Implants-Ceramic Abutments | Astra Tech, Inc. | NHA | Class II | |
| K023557 | Centricity Pacs Plus | GE Healthcare | LLZ | Class II | |
| K023458 | Tmd Safety Syringe (Fa14 Series 10Ml/fa15 Series 20Ml) | Taiject Medical Device Co., Ltd. | MEG | Class II | |
| K023417 | Suretac III, Models 7209900, 7209901 | Smith & Nephew, Inc. | JDR | Class II | |
| K023048 | Modification to Synchron Systems Benzodiazepine Reagent | Siemens Healthcare Diagnostics Inc. | JXM | Class II | |
| K023039 | Blood/solution Administration Set, Model 33.015 | Tuta Healthcare Pty Limited | BRZ | Class II | |
| K022675 | Prime-Dent Automix Dual Cure Core Build Up Material | Prime Dental Manufacturing, Inc. | EBF | Class II | |
| K022655 | Trimedyne Side Firing Needle with Vent Sheath | Trimedyne, Inc. | GEX | Class II | |
| K022159 | Piston Syringe & Hypodermic Needle | Intl. Medsurg Connection, Inc. | FMF | Class II | |
| K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex GmbH | GAT | Class II | |
| K020888 | Fundus Autoimager | Visual Pathways, Inc. | HKI | Class II | |
| K020003 | Electrocardiograph (ECG) Electrode, Non-Sterile | Bio Protech, Inc. | DRX | Class II | |
| K014218 | Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical Sensor, Model 210' | Dolphin Medical, Inc. | DQA | Class II | |
| K023697 | Steri-Mate Sterilizable Handpiece | Dentsply International, Inc. | ELC | Class II | |
| K023425 | Drapes with Absorbent Reinforcement | Medtronic, Inc. | KKX | Class II | |
| K023418 | Heartone Event Recorder and Transmitter | Aerotel Medical Systems (1998), Ltd. | DXH | Class II | |
| K023402 | 8F Launcher Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K023357 | Arcpm 1050 Resin-Hips | Biomet Orthopedics, Inc. | LPH | Class II | |
| K023350 | Esprit Ventilator with Respiratory Mechanics | Respironics, Inc. | CBK | Class II | |
| K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | KNT | Class II | |
| K023047 | Amedica Drug Screen Opiates Test | Amedica Biotech, Inc. | DJG | Class II | |
| K022955 | Amedica Drug Screen Thc Test | Amedica Biotech, Inc. | LDJ | Class II | |
| K022954 | Amedica Drug Screen Cocaine Test | Amedica Biotech, Inc. | DIO | Class II | |
| K022674 | Bird Avea Ventilator | Bird Products Corp. | CBK | Class II | |
| K022644 | Retro Repair Kit, Model Prrk5 | Spire Biomedical, Inc. | NFK | Class II | |
| K022634 | Co-Axial Introducer Needle | Promex, Inc. | DYB | Class II | |
| K023586 | Dr-Er Verfsion of Canon X-Ray Digital Cameras | Canon Medical Components U.S.A., Inc. | MQB | Class II | |
| K023511 | Excelart with Pianissimo Xg/ag Spin Edition, Model Mrt-1501/P3, P2 | Toshiba America Medical Systems, In.C | LNH | Class II | |
| K023442 | Extra Large Body Coil | GE Healthcare | MOS | Class II | |
| K023197 | Ceranum 82 | Sb Lucius, Inc. | EJT | Class II | |
| K023106 | Promotor | Ceres Fertility, Inc. | MQL | Class II | |
| K022829 | Instant-View Lh Ovulation Predicting Test | Alfa Scientific Designs, Inc. | CEP | Class I | |
| K022682 | Randox C-Reactive Protein Calibrator | Randox Laboratories, Limited | JIS | Class II | |
| K022645 | Curad | Beiersdorf, Inc. | KMF | Class I | |
| K022643 | Blastomere Biopsy Pipette, Models H-55530 and H-55540 | Swemed Lab International AB | MQH | Class II | |
| K022629 | Wmt-Tcp Bone Graft Substitute | Wrightmedicaltechnologyinc | MQV | Class II | |
| K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 | Clarus Medical, LLC | GEX | Class II | |
| K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | MUJ | Class II | |
| K021402 | Thermage Thermacool Tc System | Solta Medical, Inc. | GEI | Class II | |
| K020920 | Cozart Rapiscan Oral Fluid Drug Test - Opiate/methadone | Cozart Bioscience, Ltd. | DJG | Class II | |
| K023616 | Physiological Monitor, Model 3000 (Series) | Ivy Biomedical Systems, Inc. | DRT | Class II | |
| K023569 | Siemens Multiview Workstation Modifications | Siemens Medical Solutions USA, Inc. | MHX | Class II | |
| K023497 | Datex-Ohmeda S/5 Web Viewer with L-6Wv02 Software | GE Healthcare | MSX | Class II | |
| K023432 | Medline Asep Plus Surgical Drapes | MEDLINE INDUSTRIES, LP - Northfield | KKX | Class II | |
| K023298 | Hemcon Bandage | Hemcon, Inc. | QSY | Unclassified | |
| K023200 | Ceranum 76 | Sb Lucius, Inc. | EJT | Class II | |
| K023199 | Ceranum 50 | Sb Lucius, Inc. | EJT | Class II | |
| K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555L | Medical Action Industries, Inc. 306 | HIB | Class II |