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 |
|---|---|---|---|---|---|
| K083326 | Fluorocore 2 | Dentsply International, Inc. | EBF | Class II | |
| K082428 | N-Dex Bwc Pink Nitrile Medical Examination Glove, Non Sterile | Best Glove, Inc. | LZA | Class I | |
| K082137 | Dlms-Zirblocks | Dental Milling Laboratory Supplies (Dlms) | EIH | Class II | |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer | The Binding Site | CFN | Class II | |
| K081560 | Vascutek Cannula Graft, Model Cgs2008s | Vascutek, Ltd. | DWF | Class II | |
| K080210 | Pro Qr Advanced Formula Powder | Biolife, LLC | QSY | Unclassified | |
| K083458 | Intramedullary Fixation Rod (Ifs) | Novalign Orthopaedics, Inc. | HSB | Class II | |
| K083140 | Compex Sport Plus | Chattanooga Group, Inc. | NGX | Class II | |
| K083107 | Modification to Depuy Neuflex Pip Finger | Depuy Orthopaedics Inc. | KYJ | Class II | |
| K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | NEU | Class II | |
| K082918 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | MQV | Class II | |
| K082772 | Stimpro, Models Sp22050, Sp20100, Spp19050, Spp19100, Spp19150, Spc19050, Spc19100, Spc19150, Spc18050,spc18100,spc18150 | Life-Tech, Inc. | BSP | Class II | |
| K082690 | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Hebei Handform Plastic Products Co., Ltd. | LYZ | Class I | |
| K082377 | Tenscare Itouch Model(s) Easy and Plus | Tenscare Ltd. | GZJ | Class II | |
| K082371 | Smith & Nephew Sl-Plus Mia Standard and Lateral Femoral Hip Stem | Smith & Nephew, Inc. | LZO | Class II | |
| K090159 | Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families | Incisive Surgical, Inc. | GDW | Class II | |
| K090158 | Aplio Artida V2.0 Ssh-880Cv | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K090040 | Radifocus Glidecath (or Radifocus Glidecath Xp) | Terumo Medical Corp. | DQO | Class II | |
| K083706 | Hi-Torque Versacore Guide Wire | Abbott Vascular | DQX | Class II | |
| K083447 | Memometal Anchorage Bone Plate System, Models Plss/plsl, Plp10/plp20/plp30/plp40/plp50 | Memometal Technologies | HRS | Class II | |
| K083442 | Corridor Fixation System | Globus Medical, Inc. | MRW | Unclassified | |
| K083422 | 6F Taiga Guiding Catheter | Medtronic, Inc. | DQY | Class II | |
| K083330 | Echotip Ultra Ultrasound Needle | Wilson-Cook Medical Inc. | FCG | Class II | |
| K083304 | Temposil 2 | Coltene /Whaledent AG | EMA | Class II | |
| K083106 | Cryovalve Sg Pulmonary Valve and Conduit | Artivion, Inc. | OHA | Unclassified | |
| K082995 | Smart Dilator | Safestitch Medical | KNQ | Class II | |
| K082927 | Bioemg III | Bio-Research Associates, Inc. | KZM | Class II | |
| K082873 | Medtronic Angiographic Guide Wires | Medtronic, Inc. | DQX | Class II | |
| K082869 | Awbat-S, Awbat-D, Awbat-M | Aubrey, Inc. | KGN | Unclassified | |
| K082825 | Energist Ultraplus Variable Pulsed Light (Vpl) System | Energist Limited | GEX | Class II | |
| K082727 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | MQE | Class II | |
| K082556 | Clearcorrect | ClearCorrect, LLC | NXC | Class II | |
| K082462 | Gemlyte Electrolyte Analyzer Na+/k+/cl-/Ca++/li+ | DIAMOND DIAGNOSTICS Inc | JGS | Class II | |
| K082268 | Capnostream20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | DQA | Class II | |
| K082055 | Model Pc-860 Fetal Doppler | Shenzhen Creative Industry Co., Ltd | KNG | Class II | |
| K082019 | Freedom Total Knee System | Maxx Orthopedics Inc. | JWH | Class II | |
| K081927 | Renu Medical Oximetry Sensor, Adult, Ped, Inf,neo | Renu Medical, Inc. | NLF | Class II | |
| K081888 | Dynamik Intervertebral Body Fusion Device | Spineart SA | MAX | Class II | |
| K081886 | Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated | Karex Industries Sdn Bhd | HIS | Class II | |
| K081463 | Mebby Gentlefeed Duo Breast Pump/dual Expresser Pump | Medel S.p.A. | HGX | Class II | |
| K081398 | Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories | Advanced Medical Innovations, Inc. | GEI | Class II | |
| K080987 | Bridgepoint Medical Stingray Device and Accessories | Boston Scientific Corporation | DQY | Class II | |
| K073565 | Standard Wheelchair Platform | Design Specific Ltd | INO | Class II | |
| K073071 | Eq-Prc Lc Warfarin Genotyping Kit | Trimgen Corporation | ODW | Class II | |
| K090173 | Neuviz 16 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K090122 | Nuovoguard | U.S. Safety Syringes Co., Inc. | FOZ | Class II | |
| K090119 | Sicat Implant | Sicat GmbH & Co. KG | LLZ | Class II | |
| K083684 | Endo Vive Standard Replacement Gastrostomy Tube, Model 82Xx | Manufacturing & Research, Inc. | KNT | Class II | |
| K083439 | Synthes Epoca Shoulder Prosthesis System | Synthes (USA) Products LLC | MBF | Class II | |
| K083030 | TENS-Ems-14 | Emsi | GZJ | Class II |