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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K141774 | Zoll X Series | ZOLL Medical Corporation | MKJ | Class III | |
| K141755 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | DXN | Class II | |
| K141640 | Automatically Retractable Safety Syringes with Fixed Needle | Shantou Wealy Medical Instrument Co., Ltd. | MEG | Class II | |
| K141462 | Varia-Nci | Neurochaos Solutions, Inc. | IYN | Class II | |
| K141263 | Toggleloc and Juggerloc Implants/instruments/kits | Biomet Manufacturing Corp | JDR | Class II | |
| K141194 | Fm-3000 Fetal Monitor | Advanced Instrumentations, Inc. | HGM | Class II | |
| K140910 | Centercross Catheter | Roxwood Medical, Inc. | DQY | Class II | |
| K140569 | Antegrade Cardioplegia Cannula(n-Type) | MAQUET CARDIOPULMONARY GmbH | DWF | Class II | |
| K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | DQK | Class II | |
| K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | Bio-Analysis, Inc. | JKA | Class II | |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment for Medical Imaging (Oncovision | IYX | Class I | |
| K143098 | 3MP Color LCD monitor, RadiForce RS340 | Eizo Corporation | PGY | Class II | |
| K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | DWF | Class II | |
| K142587 | Vertical Expandable Prosthetic Titanium Rib | Depuy Synthes Spine | MDI | Class II | |
| K142347 | Amedica Valeo II Interbody Fusion Device | Amedica Corp. | MAX | Class II | |
| K142243 | LessRay with Tracking | Saferay Spine, LLC | OWB | Class II | |
| K142060 | Transom Anterior Cervical Plate | Neurostructures, Inc. | KWQ | Class II | |
| K141958 | Erb Endorectal Balloon | Edge Medical, LLC | PCT | Class II | |
| K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec Inc | OBO | Class II | |
| K141390 | Intermittent Pneumatic Compression Device | Wuhan Landing Medical Hi-Tech, Ltd. | JOW | Class II | |
| K141345 | Aequalis Fx2 | Tornier S.A.S. | PHX | Class II | |
| K140923 | Traction Polypectomy Snare | Ovesco Endoscopy AG | FDI | Class II | |
| K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | FEW | Class II | |
| K131973 | Unexef-38G Ultrasound System | Toyota Tsusho Corporation | IYN | Class II | |
| K130019 | J-Screw Compression Screw | Competitive Engineering, Inc. | HWC | Class II | |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | JDR | Class II | |
| K142099 | Cutaneous Electrodes | Bio Protech, Inc. | GXY | Class II | |
| K141839 | Premier Etch | Premier Dental Products Co | KLE | Class II | |
| K141606 | Surgical Gown | Cobes Industries Co., Ltd. | FYA | Class II | |
| K141317 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | PEK | Class II | |
| K140717 | Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration Kit | Siemens Healthcare Diagnostics Inc. | KQO | Class I | |
| K140595 | Third Eye Panoramic Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | FDF | Class II | |
| K140586 | Ascend Electrode | Neurometrix, Inc. | GXY | Class II | |
| K140222 | Saiph Knee System | MatOrtho Limited | JWH | Class II | |
| K133827 | A-Link Z | Osteo Vasive, LLC | OVD | Class II | |
| DEN140025 | BrainScope Ahead 100 | Brainscope | PIW | Class II | |
| K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | Sofradim Production | FTL | Class II | |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | GAM | Class II | |
| K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | Stryker Corp. | DQY | Class II | |
| K142462 | Restoration Anatomic Shell | Stryker Orthopaedics | LPH | Class II | |
| K142413 | TITAN Modular Total Shoulder System | Ascension Orthopedics, Inc. | KWS | Class II | |
| K142315 | MINOP Disposable Introducer 26F | Aesculap Inc | GWG | Class II | |
| K142161 | Itotal Cruciate Retaining (Cr) Knee Replacement System, Itotal Posterior Stabilized (Ps) Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K142093 | V20 System | Viora, Ltd. | GEX | Class II | |
| K141994 | Bulk Fill Flowable Composite | Novocol, Inc. | EBF | Class II | |
| K141968 | Nuvasive Nvm5 System | NuVasive Inc | PDQ | Class II | |
| K141617 | Cleaner Rotational Thrombectomy System | Rex Medical LP | QEW | Class II | |
| K141471 | Journey II Xr Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K141342 | Wearable Therapy Garments | Axiobionics, LLC, Center for Neuroprosthetics | GXY | Class II |