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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | PBX | Class II | |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co.,Ltd | NHA | Class II | |
| K230106 | General Cutting Straight | Nakanishi Inc. | EGS | Class I | |
| K223663 | SIMDA Abutment | Simda Co.,Ltd. | NHA | Class II | |
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical Inc | IMJ | Class II | |
| K223259 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech Inc | FRO | Unclassified | |
| K222035 | Avatar Medical Software V1 | Avatar Medical | LLZ | Class II | |
| K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/a | BTL | Class II | |
| K231178 | ACTERA™ hip system | ConforMIS, Inc. | MEH | Class II | |
| K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | LLZ | Class II | |
| K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | Suzhou Endophix Co., Ltd. | MBI | Class II | |
| K230803 | Adas 3D | ADAS3D Medical S.L | LLZ | Class II | |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | LZA | Class I | |
| K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | OAP | Class II | |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | QDQ | Class II | |
| K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | OMB | Class II | |
| K231464 | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) | 3M Company, Unitek Orthodontic Products | NXC | Class II | |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care Inc. | QJP | Class II | |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| K230631 | Kodiak™ Dual Port Coaxial Introducer Kit | Argon Medical Devices, Inc | DYB | Class II | |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd | KLE | Class II | |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K230460 | Laser Thermal Therapy Kit | Elesta SpA | GEX | Class II | |
| K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | Jiangxi Royall Smart Technology Co., Ltd. | NUH | Class II | |
| K230373 | HELIOS 785 Pico | Laseroptek | GEX | Class II | |
| K223860 | Integrity™ Bone Staple Fixation System | Anika Therapeutics, Inc. | MBI | Class II | |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | |
| K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | LJE | Unclassified | |
| K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co. Ltd | EZD | Class II | |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | DKZ | Class II | |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Medical | DHA | Class II | |
| K230769 | PrevisEA Device | Entac Medical, Inc. | DQD | Class II | |
| K230537 | Klassic Knee Revision System | Total Joint Othopedics, Inc. | JWH | Class II | |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | Stryker Corp. | KRO | Class II | |
| K230375 | Biomonitor IV | BIOTRONIK AG | MXD | Class II | |
| K223846 | iLet® ACE Pump | Beta Bionics, Inc. | QFG | Class II | |
| K223486 | SafeBreak® Vascular | Lineus Medical | QOI | Class II | |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | Microlife Intellectual Property GmbH | DXN | Class II | |
| K222833 | Ventana™ C Spinal System | Spinal Elements, Inc | ODP | Class II | |
| K222703 | ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) | Moving Life Ltd | INI | Class II | |
| K222545 | Disposable Medical Mask | Guangzhou Fuzelong Hygiene Material Co.,Ltd. | FXX | Class II | |
| K221323 | Exactech® Alteon® Short Tapered Wedge | Exactech, Inc. | LZO | Class II | |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | Spectrum Medical Inc | KFM | Class II | |
| K220402 | VirtuOst | O.N. Diagnostics, LLC | KGI | Class II | |
| K212758 | Autoplaque | Cedars-Sinai Medical Center: Aim | LLZ | Class II | |
| K231113 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II |