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 |
|---|---|---|---|---|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | OZT | Class II | |
| K151916 | TRI Dental Implant System | Tri Dental Implants Int. AG | DZE | Class II | |
| K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | CAH | Class II | |
| K151413 | Always/Tampax bladder supports | Procter & Gamble Co. | HHW | Class II | |
| K151359 | ROSA Brain | MedTech LLC | HAW | Class II | |
| K151126 | Foresight Intracardiac Echocardiography (ICE) System | Colibri Technologies, Inc. | DQO | Class II | |
| K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | Cook Incorporated | KRD | Class II | |
| K150931 | MReye Embolization Coils | Cook Incorporated | KRD | Class II | |
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corp. | CAW | Class II | |
| K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | Moller Medical GmbH | JXG | Class II | |
| K150828 | O-RING Condom | O-Ring Products, LLC | HIS | Class II | |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | MQH | Class II | |
| K150682 | CUSA Excel+ | Integra LifeSciences Corporation | LFL | Unclassified | |
| DEN150005 | Newa Skin Therapy System | Endymed Medical Inc. | PAY | Class II | |
| K153344 | Asahi REXEED-S Series Dialyzer | Asahi Kasei Medical Co., Ltd. | KDI | Class II | |
| K153310 | Klassic Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | NEU | Class II | |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | KYF | Class II | |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | Halyard Health | PNR | Class II | |
| K152636 | Laser Dock | Patient Pocket, LLC | GEX | Class II | |
| K152491 | MoMe Software Platform | Infobionic, Inc. | DSI | Class II | |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Abbott Medical | NBW | Class II | |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics Inc | OCC | Class II | |
| K152291 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | FRG | Class II | |
| K152219 | Pk Aim | Gyrus ACMI, Inc. | GEI | Class II | |
| K152155 | ARCHITECT 2nd Generation Testosterone | Abbott Medical | CDZ | Class I | |
| K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | DRN | Class II | |
| K151810 | Bpump Blood Pressure Cuff | Shenzhen Pump Medical System Co., Ltd. | DXQ | Class II | |
| K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | LEJ | Class II | |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | Sentec AG | LKD | Class II | |
| K151062 | WASTON Metallic Intramedullary Nail System | Changzhou Waston Medical Appliance Co., Ltd. | HSB | Class II | |
| K151022 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit | Becton Dickinson & Co | PMG | Class II | |
| K150792 | Next Science Wound Gel | Next Science, LLC | FRO | Unclassified | |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | OK Biotech Co., Ltd. | NBW | Class II | |
| K153480 | ClearVue850 Diagnostic Ultrasound System | Philips Health Care | IYN | Class II | |
| K153450 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K153376 | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | |
| K153362 | AquaShield system CO2, AquaShield system-PENTAX | United States Endoscopy Group, Inc. | FEQ | Class II | |
| K152322 | Resolve 2.0 | Denali Corporation | PME | Class II | |
| K152118 | Zenostar MT, Zenostar Color Liquids | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire | Boston Scientific Corporation | DQX | Class II | |
| K151279 | Counter OTC TENS Device, Model CSD-737Z | Counter Scientific Development (Gz), Ltd. | NUH | Class II | |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | DRT | Class II | |
| K150908 | XM-01 Electronic Automatic Blood Pressure Monitor | Sky Innovation Technology ( Shanghai) Limited | DXN | Class II | |
| K150806 | PulseFlowDF | Pulseflow Technologies | JOW | Class II | |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings, Inc. | NLQ | Unclassified | |
| K153483 | Balloon controller PB-30 | FUJIFILM Healthcare Americas Corporation | FDF | Class II | |
| K152945 | Alevicyn SG Antipruritic Gel | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K152651 | AccuLIF TL and PL Cage | Stryker Corp. | MAX | Class II |