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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K003338 | Bio-Eye II Orbital Implant | Integrated Orbital Implants Inc | HPZ | Class II | |
| K003041 | Ultrasound Scanner Type 2101 | BK Medical ApS | IYO | Class II | |
| K002910 | Holy Dragon Acupuncture Needles | Anc Import & Export Co., Ltd. | MQX | Class II | |
| K002469 | Implantmed Si-95 115 (100-130 V) and Si-95 230 (220-240 V) | W & H DentalWerk Buermoos GmbH | EBW | Class I | |
| K000776 | Medtronic Dlp Arterial Cannulae with 3D Tip | Medtronic Cardiac Surgical Products | DWF | Class II | |
| K010247 | Shanghai Chinastar Power-Free Blue Nitril Examination Gloves | Shanghai China Star Corp | LZA | Class I | |
| K010238 | Actherm Digital Clinical Thermometer, Models Act2000, Act2010, Act2000+, Act2010+, Act2020+ | Actherm, Inc. | FLL | Class II | |
| K004048 | Sensigrip Ltc Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) | Tillotson Healthcare Corp. | LYY | Class I | |
| K003958 | Coalescent U-Clip Delivery and Disposal Device | Coalescent Surgical | FZP | Class II | |
| K003760 | Tai-Chi Acupuncture Needles | Lhasa Medical, Inc. | MQX | Class II | |
| K003383 | Palmlight | Ultradent Products Inc. | EBZ | Class II | |
| K003293 | Excite Dsc | Ivoclar North America, Inc. | KLE | Class II | |
| K993600 | Multi Interferential Stimulator, Model Tr-841 | Nisha Communication Industries | LIH | Class II | |
| K010081 | Acumatch L-Series Unipolar Endoprosthesis | Exactech, Inc. | KWY | Class II | |
| K010050 | Advia Centaur and Acs: 180 Folate Immunoassay | Bayer Diagnostics Corp. | CGN | Class II | |
| K010001 | Livesure Thc Screen Test | Pan Probe Biotech, Inc. | LDJ | Class II | |
| K003854 | Intravascular Administration Set | Infusion Devices, Inc. | FPA | Class II | |
| K003796 | Advia 120 Hematology | Bayer Corp. | GKZ | Class II | |
| K003704 | Optovent Respons, Optovent Renee (Optovent Respons without Pulse Oximetry Module) | Optovent AB | BZQ | Class II | |
| K003597 | Immulite Homocysteine Model Lkho1 / Immulite 2000 Homocysteine Model L2kho2 | Siemens Healthcare Diagnostics Inc. | LPS | Class II | |
| K003478 | Triology Acetabular System 46Mm Large Head Liners, Model 6310 | Zimmer GmbH | LPH | Class II | |
| K002877 | Mictec Endoscopes and Accessories | Dufner Instrumente GmbH | GEI | Class II | |
| K002642 | Miniquant D-Dimer, Model 1447 | Biopool Intl., Inc. | DAP | Class II | |
| K002585 | Randox Transferrin | Randox Laboratories, Limited | DDG | Class II | |
| K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602 | Medical Devices Inc. | MKJ | Class III | |
| K002201 | Electrostatic Hydrophobic Breathing Filter | Abbott Medical | CAH | Class II | |
| K001988 | Modular | Heyer America, Inc. | BSZ | Class II | |
| K001781 | Curry Multimodal Neuroimaging Software | Neurosoft Ltd | OLX | Class II | |
| K993229 | Analgesic Pulser, Model Ap-439 | Johari Electro-Tech Co. | GZJ | Class II | |
| K010057 | Modification to Artoscan M | Esaote North America, Inc | LNH | Class II | |
| K004037 | X-Ray System Xr-Mx | Karl Storz Endoscopy-America, Inc. | JAA | Class II | |
| K003945 | Opdima | Siemens Medical Solutions USA, Inc. | IZH | Class II | |
| K003773 | Clean Scrape | Webb Research Ii, Inc. | GEI | Class II | |
| K003710 | Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera Coupler Model 7207905 | Smith & Nephew, Inc. | FET | Class II | |
| K003655 | Phs-63 Pediatric Head and Spine Array Coil | Mri Devices Corp. | MOS | Class II | |
| K003636 | Portalvision | Varian Medical Systems, Inc. | IYE | Class II | |
| K003489 | Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 | Medical Illumination International, Inc | FSS | Class II | |
| K003437 | Odyssey Lx, Model 211320 | Philips North America LLC | LLZ | Class II | |
| K003436 | Surgi-Vision Guidewire Coil | Surgi-Vision, Inc. | MOS | Class II | |
| K002429 | Select Seed I-125 | Nucletron BV | KXK | Class II | |
| K002407 | Easyelectrolyte Na/k/li Analyzer & Rapidlyte Na/k/li Analyzer | Medica Corp. | JGS | Class II | |
| K002237 | P3imrt Tm | Philips North America LLC | MUJ | Class II | |
| K002227 | Wandy Silicone Conductive Rubber Pad | Wandy Rubber Industrial Co., Ltd | GXY | Class II | |
| K002219 | Wandy Self-Adhesive Neurostimulation Electrode | Wandy Rubber Industrial Co., Ltd | GXY | Class II | |
| K002075 | Ace Sds 3.75Mm Screw Dental Implant | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K001965 | Safe-Point Vac, Safe-Point M-D Blood Collection Systems | North American Medical Products, Inc. | FMI | Class II | |
| K990284 | Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable | Baylis Medical Co., Inc. | DXF | Class II | |
| K010142 | Oco Dental Implant | O Co., Inc. | DZE | Class II | |
| K010099 | Zynergy Z3k Balloon Guided Pacing and Monitoring Catheter | Zcv,Inc. | LDF | Class II | |
| K010098 | Modification to Cavermap Surgical Aid | Uromed Corp. | FGM | Class I |