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 |
|---|---|---|---|---|---|
| K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters | Alvimedica Tibbi Urunler Sanayi ve Dis Ticaret A.S | DQO | Class II | |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | ZimVie US Corp LLC | NHA | Class II | |
| K143437 | Droplet Pen Needles | HTL-Strefa S.A. | FMI | Class II | |
| K142830 | Ophthalmed Bending Laser Probes | Ophthalmed LLC | HQF | Class II | |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing Corp | JDI | Class II | |
| K142357 | DuraSheath Introducer Sheath System | Contract Medical International GmbH | DYB | Class II | |
| K141110 | Cryocare Cs Surgical System | Varian Medical Systems, Inc. | GEH | Class II | |
| K133279 | Medihoney Wound Dressings | Derma Sciences, Inc. | FRO | Unclassified | |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker Corp. | HBW | Class II | |
| K151178 | VariAx 2 Wrist Fusion System | Stryker Trauma GmbH | HRS | Class II | |
| K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | OOE | Class II | |
| K151031 | Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | NKG | Class II | |
| K150766 | Carestream DRX-1 System | Eastman Kodak Company | MQB | Class II | |
| K150053 | STALIF C; STALIF C-Ti | Centinel Spine, LLC | OVE | Class II | |
| K150029 | Habib EUS RFA | Emcision, Ltd. | GEI | Class II | |
| K143110 | GALAXY MIS Screw System | BM Korea Co., Ltd. | NKB | Class II | |
| K143093 | 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) | Hotspur Technologies | LIT | Class II | |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co Ltd | KKX | Class II | |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | Foshan Nanhai Plus Medical Co Ltd | FYA | Class II | |
| K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX | Medikro Oy | BZG | Class II | |
| K151419 | Gf50a | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K151272 | Henschke Titanium Applicator Set | Nucletron BV | JAQ | Class II | |
| K151221 | Kubtec DIGIVIEW 395 | Kub Technologies, Inc. | MQB | Class II | |
| K151192 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K150981 | SMV Scientific Bone Screws | Smv Scientific | HWC | Class II | |
| K150868 | Solana GAS Assay, Solana instrument | Ortho-Clinical Diagnostics, Inc. | PGX | Class II | |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products LLC | DZJ | Class II | |
| K150783 | Progressive Orthopaedic Total Knee System | The Progressive Orthopaedic Company, LLC | JWH | Class II | |
| K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research/Medeco International | KLE | Class II | |
| K150218 | Fill-Up! | Coltene /Whaledent AG | EBF | Class II | |
| K150002 | iNSIGHT Color Doppler Ultrasound System | Saset (Chengdu), Inc. | IYN | Class II | |
| K143476 | Digi-One | Rimed, Ltd. | IYN | Class II | |
| K143438 | Flowtron ACS900 | Arjo (Suzhou) Co., Ltd. | JOW | Class II | |
| K143020 | LiverMultiScan | Mirada Medical Limited | LNH | Class II | |
| K142912 | Merits Yoga Power Scooter, S542 | Merits Health Products, Inc. | INI | Class II | |
| K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems Inc. | OLT | Class II | |
| K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | HEB | Class II | |
| K142548 | Midsleeve | Medical Innovation Development | KNT | Class II | |
| DEN140018 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | PLA | Class II | |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | Diasorin Inc. | CEW | Class II | |
| K150666 | uNion Cervical Plate System | ulrich medical USA Inc | KWQ | Class II | |
| K150540 | Instru-Safe Instrument Protection System | Summit Medical, LLC | KCT | Class II | |
| K141348 | Visco Soft Contact Lens | Visco Vision Inc. | LPL | Class II | |
| K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | BH Medical Products Co., Ltd | FXX | Class II | |
| K151230 | Arthrex FiberTak Anchors | Arthrex GmbH | MBI | Class II | |
| K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | HSB | Class II | |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | KXK | Class II | |
| K150781 | Tissue Removal Pouch | Boehringer Laboratories, LLC | GCJ | Class II | |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties, Inc. | EJK | Class II |