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 |
|---|---|---|---|---|---|
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | FCG | Class II | |
| K150880 | Tablo Console with Wireless Capability | Outset Medical, Inc. | KDI | Class II | |
| K150818 | Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System | Zimmer GmbH | KTT | Class II | |
| K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | Rayence Co., Ltd. | MUH | Class II | |
| K150626 | Rush Medullary Pins | Zimmer GmbH | HTY | Class II | |
| K150615 | Vaginal Moisturizing Gel | Combe Incorporated | NUC | Class II | |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | DWE | Class II | |
| K150522 | G7 Dual Mobility System | Zimmer GmbH | LPH | Class II | |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | FMP | Class I | |
| K150035 | V10 system | Viora, Ltd. | PBX | Class II | |
| K143679 | Nuance FLOW | Den-Mat Holdings, LLC | EBF | Class II | |
| K143540 | Stryker MIS Attachments and Cutting Accessories | Stryker Corp. | HBE | Class II | |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | ZimVie US Corp LLC | NHA | Class II | |
| K143448 | Sonendo GentleWave System | Sonendo Inc | ELC | Class II | |
| K143212 | Bifix Temp | Voco GmbH | EMA | Class II | |
| K143101 | Helio A7 Manual Wheelchair, Move Manual Wheelchair | Motion Composites | IOR | Class I | |
| K142469 | 2D Mercy TAPE & 3D Mercy TAPE | Children'S Mercy Hospital | PIR | Class I | |
| K142212 | Pyrenees Cervical Plate System | K2M, Inc | KWQ | Class II | |
| K142162 | Merits Transformer Power Scooter, S941 | Merits Health Products, Inc. | INI | Class II | |
| K142087 | Cova Monitoring System | Tosense, Inc. | MWI | Class II | |
| K141146 | Invisiport | Stealth Therapeutics, Incorporated | LJT | Class II | |
| K141036 | Bgm009 Blood Glucose Monitoring System | Apex Biotechnology Corp. | NBW | Class II | |
| K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | DXH | Class II | |
| K150913 | Incite Anchored Cervical Interbody Device | Incite Innovation, LLC | OVE | Class II | |
| K150813 | iTClamp50 | Innovative Trauma Care Inc | DXC | Class II | |
| K150649 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | HRS | Class II | |
| K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc | LPL | Class II | |
| K150361 | ViSi Mobile Monitoring System | Sotera Wireless | MWI | Class II | |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | Acon Laboratories, Inc. | JIR | Class I | |
| K150256 | Silverlon Burn Contact Dressings | Argentum Medical, LLC | FRO | Unclassified | |
| K143272 | ApneaLink Air | Resmed Germany, Inc. | MNR | Class II | |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Co. | JJY | Class I | |
| K142820 | BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear | ABB Optical Group LLC. | LPL | Class II | |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K150974 | aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium | AAP Implantate AG | HWC | Class II | |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | Intuitive Surgical, Inc. | NAY | Class II | |
| K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | PDU | Class II | |
| K150633 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | GCJ | Class II | |
| K150579 | Cardinal Health External Fixation System | Cardinalhealth | KTT | Class II | |
| K150520 | DARCO Locking Bone Plate System | Wrightmedicaltechnologyinc | HRS | Class II | |
| K150456 | Arthrex Plates, Screws, and Staples | Arthrex GmbH | HRS | Class II | |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine | MNH | Class II | |
| K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | HWC | Class II | |
| K150188 | SMV Scientific 4.5 mm Bone Screws | Summit Medventures | HWC | Class II | |
| K143595 | NuVasive(R) CCX-L Interbody System | Nu Vasive, Incorporated | MAX | Class II | |
| K143351 | iCase Contact Lens Case | Novabay Pharmaceuticals, Inc | LRX | Class II | |
| K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters | Smith & Nephew, Inc. | OMP | Class II | |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | KWP | Class II | |
| K142839 | GenCut Core Biopsy System | Medtronic, Inc. | EOQ | Class II |