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 |
|---|---|---|---|---|---|
| K050980 | Ultrasonic Bio-Microscope, Model P60 | Paradigm Medical Industries, Inc. | IYO | Class II | |
| K050875 | U-Balloon Dilation Catheter | C.R. Bard Inc | EZN | Class II | |
| K050873 | Canalizer Hydrophilic Guide Wire | Medical Device Technologies, Inc. | DQX | Class II | |
| K050850 | Xpand Corpectomy Spacer | Globus Medical, Inc. | MQP | Class II | |
| K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | LLZ | Class II | |
| K050766 | Explant Osteonecrosis Intervention Implant Removal System | Zimmer Trabecular | HWE | Class I | |
| K050718 | Ddrcombi Trauma | Swissray International, Inc. | MQB | Class II | |
| K050693 | Accent | Air Techniques, Inc. | MUH | Class II | |
| K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | JEY | Class II | |
| K050632 | Advia Ims Direct Hdl Cholesterol Assay | Medrad, Inc. | LBS | Class I | |
| K050261 | V.a.c. Granufoam Silver Protection Dressing | KCI USA, Inc. | OMP | Class II | |
| K050185 | Powerhohn and Powerline Catheters | C.R. Bard Inc | LJS | Class II | |
| K050166 | Portex Emergency Cricothyroidotomy Kit | Abbott Medical | BWC | Class II | |
| K051203 | Bluelex | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-Co & Accesacc | GE Healthcare | CCL | Class II | |
| K050904 | CPAP Humidifier, Model Hc238jhu | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K050898 | Smith & Nephew Vulcan Articular Cartilage Probe, Model 721Xxxx | Smith & Nephew, Inc. | GEI | Class II | |
| K050610 | Salute Fixation System | Davol Inc., Sub. C.R. Bard, Inc. | GDW | Class II | |
| K050389 | Ultra-Soft Sv Balloon Dilatation Catheter | Boston Scientific Corporation | DQY | Class II | |
| K050248 | Electrode | Electramold | DRX | Class II | |
| K043249 | Atrion Needlevise Large-Bore Sharps Securing Device | Atrion Medical Products, Inc. | FMI | Class II | |
| K043234 | Light Drape | Wrapped in Comfort | MMP | Class II | |
| K043149 | Firstline Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Steel Blue Color) | Firstline, LLC | LZA | Class I | |
| K051040 | Heparin Dose Response Controls, Model 306-20 Por | Medtronic Perfusion Systems | JOX | Class II | |
| K050982 | Bd Phonix Automated Microbiology System - Cefotaxime Strep (0.0625-4Ug/ml) | Becton Dickinson & Co | LON | Class II | |
| K050897 | Navipro Shoulder Software Module | Kinamed Inc | HAW | Class II | |
| K051181 | Custom-Hip Tool | Orthopedic Sciences, Inc | HRS | Class II | |
| K051170 | Gemini Gxl | Philips North America LLC | KPS | Class II | |
| K051063 | Polyaxial Hemispherical Spinal Screws | Scient'X | MNI | Class II | |
| K051055 | Intrabeam System | Carl Zeiss Surgical GmbH | JAD | Class II | |
| K051032 | Titanium-Hip Tool | Orthopedic Sciences, Inc | HRS | Class II | |
| K050976 | Vitek 2 Gram Positive Trimethoprim/sulfamethoxazole | bioMerieux, Inc. | LON | Class II | |
| K050943 | Ge Viewpoint | General Electric Co. | LLZ | Class II | |
| K050888 | Integra Immobilization System | Diacor, Inc. | IYE | Class II | |
| K050735 | Mc6a | Macan Engineering Co. | EKZ | Class II | |
| K050595 | Ft2000 Sequencer for Muscle Stimulator | Midwest Development | IPF | Class II | |
| K050305 | One Step Hcg Pregnancy Urine Test Formats: Strip, Cassette and Midstream, Models Bm-1-1, Bm-1-2, Bm-1-3, Bm-2-1, Bm-2-2 | Bioscreen Medical, Inc. | LCX | Class II | |
| K050098 | Ddat Omt | Ddat(Uk), Ltd. | GWN | Class II | |
| K043592 | Reprocessed Endoscopic Trocar | Sterilmed Inc | NLM | Class II | |
| K051232 | D731 Micro 20 Ph.i.s.i.o Pediatric Arterial Filter, D733 Micro 40 Ph.i.si.o Pediatric Arterial Filter | Dideco S.p.A. | DTM | Class II | |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 Elan | Mds Nordion | MOT | Unclassified | |
| K050929 | The Hermes System | Palaistra Systems, Inc. | DRG | Class II | |
| K050865 | Bd Phoenix Automated Microbiology System-Trimethoprim-Sulfamethoxazole 0.0625/1.2-16/304 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3Kg011 | Scantibodies Laboratory Inc. | CKG | Class II | |
| K050684 | Atlantis Pv | Boston Scientific Corporation | DQO | Class II | |
| K050678 | Motifmesh Soft Tissue Patch | Proxy Biomedical Ltd. | FTL | Class II | |
| K050546 | Acon +/- Midstream Pregnancy Test | Acon Laboratories, Inc. | LCX | Class II | |
| K050534 | Xpert Self-Expanding Transhepatic Biliary Stent System | Abbott Medical | FGE | Class II | |
| K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | CGA | Class II | |
| K041971 | Wimrt Module for Artp Planning System | Prodigm Group, Inc. | MUJ | Class II |