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 |
|---|---|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | DTW | Class II | |
| K150342 | Touch Ultrasound | Eastman Kodak Company | IYO | Class II | |
| K150333 | MedSource Sharps Dart | Medsource International, LLC | MMK | Class II | |
| K150217 | Orthophos Sl | Sirona Dental Systems GmbH | OAS | Class II | |
| K150213 | Subtalar Spacer System (STS) | Wrightmedicaltechnologyinc | HWC | Class II | |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | PDZ | Class II | |
| K143606 | MultiBand SENSE | Philips Medical Systems Nethrlands BV | LNH | Class II | |
| K143531 | Rapid Therapy System | Magstim Inc. | OBP | Class II | |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | Benq Materials Corporation | QSY | Unclassified | |
| K143399 | Stryker Footed Attachments and Cutting Accessories | Stryker Corp. | HBE | Class II | |
| K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | BSK | Class II | |
| K140905 | Dermafine | Invado Pharmaceuticals | FRO | Unclassified | |
| K150954 | Elite L Expandable Lumbar Fusion System | Innova Spinal Technologies, LLC | MAX | Class II | |
| K150663 | Diagnostic X-ray System | Osko, Inc. | KPR | Class II | |
| K150359 | Tensyn Plug | Dallen Medical, Inc. | HTN | Class II | |
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators | MAQUET CARDIOPULMONARY GmbH | DTZ | Class II | |
| K150036 | Blue Mountain Cervical Plate System | Spineway | KWQ | Class II | |
| K143759 | JAZZ System | Implanet | OWI | Class II | |
| K143750 | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | Apex Biotechnology Corp. | CGA | Class II | |
| K143667 | GC KommonBase | GC Orthodontics America Inc. | DYH | Class II | |
| K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K143185 | entré Model PD08-U | Tactile Systems Technology Inc | JOW | Class II | |
| K143147 | Gemini Bonded Sterilization Wrap | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K142744 | Mecta-C TiPEEK | Medacta International SA | ODP | Class II | |
| K142717 | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case | Ni Hau Industrial Co., Ltd. | LRX | Class II | |
| K142487 | Chesapeake Stabilization System | K2M, Inc | OVD | Class II | |
| K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | BYI | Class II | |
| K142192 | Insightra Freedom Ventral Hernia Repair System | Insightra Medical Inc | FTL | Class II | |
| K142032 | MRI Patient Monitoring System Tesla M3 | MIPM Mammendorfer Institut fur Physik und Medizin GmbH | MWI | Class II | |
| K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | IYO | Class II | |
| K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies Ltd | DSY | Class II | |
| K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | PZI | Class II | |
| K150056 | Luxisse+ | Heany Industries, Inc. | EIH | Class II | |
| K143585 | Electric Breast Pump | Shantou Xinghe Electrical Apparatuses Co., Ltd. | HGX | Class II | |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Advanced Medical Optics, Inc. | MSS | Class I | |
| K150536 | Terumo Circuit Tubing | Terumo Cardiovascular Systems Corporation | DWF | Class II | |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | NQQ | Class II | |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker Corp. | JEY | Class II | |
| K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte Ltd | FXX | Class II | |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | Erbe USA Inc | GEH | Class II | |
| K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | LPH | Class II | |
| K143714 | Powerheart G5 AED | ZOLL Medical Corporation | MKJ | Class III | |
| K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | DQY | Class II | |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | Euroimmun US Inc. | LSR | Class II | |
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE | Biologic Therapies, Inc. | KNW | Class II | |
| K141576 | Maxima PRO 45L | Kavo do Brasil Industria E Comercio Ltda | EFB | Class I | |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | ZOLL Medical Corporation | MKJ | Class III | |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | ZOLL Medical Corporation | MKJ | Class III | |
| K143734 | Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics GmbH | JJX | Class I |