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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K251327 | Xerf | Lutronic Corporation | GEI | Class II | |
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | CCL | Class II | |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik a/S | OBP | Class II | |
| K251098 | Identity Revision Humeral Stems | Zimmer GmbH | MBF | Class II | |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | FET | Class II | |
| K250207 | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited | HGX | Class II | |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | EOB | Class II | |
| K232456 | Rw-1 | Mediott, Inc. | LLZ | Class II | |
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FAJ | Class II | |
| K252170 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | |
| K251801 | Diode laser device (BM091) | Hebei Newangie Technology Co., Ltd | GEX | Class II | |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton Dickinson & Co | LON | Class II | |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | KNS | Class II | |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik a/S | OBP | Class II | |
| K250817 | Coretech Compression System (Coretech RHB3003) | VIVE Health LLC | JOW | Class II | |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | NEY | Class II | |
| K250540 | SABER-C System | Elevation Spine | OVE | Class II | |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | KTT | Class II | |
| K250142 | Water-based Lubricant | Global Protection Corp. | NUC | Class II | |
| K243972 | Plain Water-based Lubricant | Global Protection Corp. | NUC | Class II | |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra LifeSciences Production Corporation | JXG | Class II | |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology Inc | HQC | Class II | |
| K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | EBC | Class II | |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. | OHS | Class II | |
| K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) | QIH | Class II | |
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation | GXD | Class II | |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-Care | LLZ | Class II | |
| K250622 | Succession™ AFN System | Ortho Solutions Inc | HSB | Class II | |
| K250309 | Btl-199 | BTL Industries, Inc | QPL | Class II | |
| K243765 | LuMon(TM) System | Sentec AG | QEB | Class II | |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K252326 | InterSpace GV Hip Spacer | Tecres SpA | KWL | Class II | |
| K252239 | InVision™ 3T Recharge Operating Suite | IMRIS Imaging, Inc. | LNH | Class II | |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care, Inc. | FPA | Class II | |
| K251432 | Olo | El.En S.p.A. | GEX | Class II | |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corp. | DXN | Class II | |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. | LLZ | Class II | |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | DPS | Class II | |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd | GCJ | Class II | |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd | GCJ | Class II | |
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra LifeSciences Production Corporation | JXG | Class II | |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | MBI | Class II | |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical, LP | PHX | Class II | |
| K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | MAX | Class II | |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare Ltd. | ONB | Class II | |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte Ltd | BZQ | Class II | |
| K250434 | trophon2 | Nanosonics Limited | OUJ | Class II | |
| K250246 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K244016 | iPETcertum (v1.0) | Claritas Healthtech Limited | LLZ | Class II | |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical Inc | KFM | Class II |