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 |
|---|---|---|---|---|---|
| K951904 | Synthes (USA) [Synthes] Point Contact Fixator Plate [Pc-Fix] | Synthes (USA) Products LLC | JDO | Class II | |
| K951798 | Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit | Helix Diagnostics, Inc. | LJM | Class II | |
| K951775 | Ceralas Diode Laser System (Model Ceralas D50) | Ceram Optec, Inc. | GEX | Class II | |
| K951551 | Fredeic Beausoceil | Pascal Mathieux | HQY | Class I | |
| K951473 | Ultimax | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K951027 | Depuy Amk Co-Cr Finned Tibial Tray | Depuy, Inc. | JWH | Class II | |
| K950218 | Oms Slimline Phaco Handpiece | Optical Micro Systems, Inc. | HQC | Class II | |
| K950178 | Pharma-Plast Pureline(tm) Comfort(tm) & Clini Sofs Plus Subcutaneous Infusion Set | Pharma-Plast Intl. A/S | LZE | Class I | |
| K945754 | Newox2 | Bci Intl., Inc. | DQA | Class II | |
| K925078 | Spectradop | Bennett and Assoc., Inc. | JOP | Class II | |
| K952854 | Pulpdent Glass Ionomer Cements | Pulpdent Corporation | DYH | Class II | |
| K952663 | 60 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt, Inj. Site, Clamp | Distronic Sterile Products, Inc. | FPK | Class II | |
| K952561 | Water Jel Burn Kit | Water-Jel Technologies, LLC | LRR | Not classified | |
| K952539 | Radiology Packs | Sterile Concepts, Inc. | LRO | Class II | |
| K952516 | Pro-Vent, Line Draw, Pulsator | Smiths Industries Medical Systems, Inc. | JKA | Class II | |
| K952334 | Dressing Change Tray | Busse Hospital Disposables | MCY | Class II | |
| K952289 | Welch Allyn Fiber Optic Headlignt | Welch Allyn Inc | HPQ | Class II | |
| K952211 | Amerlite Tsh-30 Ultrasensitive Assay (Lan.0010q/2010q) | Johnson & Johnson Clinical Diagnostics, Inc. | JLW | Class II | |
| K951941 | Citation Multiple Use Delta Scope | Citation Medical Corp. | HRX | Class II | |
| K951924 | Organic Tampons | Eco Yarn Co. | HEB | Class II | |
| K951843 | Ref. 4102Cv Intermediary Tubing, Ref. 4509Cv Sterile Zone Kit | Future Medical Systems, Inc. | HRX | Class II | |
| K951724 | Quantitative EEG Analysis Software | Neuroconcepts, Inc. | OLT | Class II | |
| K951606 | Kis-II Implant Fixtures | Implant Center of the Palm Beaches | DZE | Class II | |
| K951605 | Spacelabs Medical Casemaster Information Management System | Spacelabs, Inc. | DSH | Class II | |
| K951537 | Glucometer Elite M Blood Glucose Meter | Bayer Corp. | CGA | Class II | |
| K951507 | Principle Component EEG Analysis Software | Neuroconcepts, Inc. | GWQ | Class II | |
| K950154 | 1.2Mm Disposable Neuroview(tm) Performed Endoscope and Accessories | Neuro Navigational Corp. | GWG | Class II | |
| K945937 | Te-800 Pelvic Floor Exerciser | Myo/Kinetic Systems, Inc. | HIR | Class II | |
| K945706 | Bone Drill | Osteo Implant Corp. | DZE | Class II | |
| K945592 | Vlv Solodraw(tm) Dual Chamber Piston Syringe | VLV Associates, Inc. | FMF | Class II | |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160 | Clarus Medical Systems, Inc. | GWG | Class II | |
| K944966 | Unipolar Atrial Temporary Pacing Lead,model 6492 | Medtronic Blood Systems, Inc. | LDF | Class II | |
| K944957 | Temporary Myocardial Pacing Lead, Model 6500 | Medtronic Blood Systems, Inc. | LDF | Class II | |
| K944956 | Unipolar Pediatric Temporary Pacing Lead, Model 6491 | The Heart Valve Div. Medtronic Cardiovascular Surg | LDF | Class II | |
| K942988 | Filtered Extension Sets | B. Braun of America, Inc. | FPA | Class II | |
| K942543 | Aneroid Sphygmomanometers/mercurial Sphygmomanometersrs | Sankei Co., Ltd. | DXN | Class II | |
| K935588 | Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in Perspiration | Sudormed, Inc. | JKA | Class II | |
| K935573 | Amphetamines Micro-Plate Eia | Solarcare Technologies Corp,Inc. | DKZ | Class II | |
| K935565 | Opiates Micro-Plate Assay | Solarcare Technologies Corp,Inc. | DJG | Class II | |
| K935564 | Sudormed Sweat Patch Specimen Container for Collection of Opiates in Perspiration | Sudormed, Inc. | JKA | Class II | |
| K934775 | Stc Cocaine Metabolite Eia | Solarcare, Inc. | DIO | Class II | |
| K934435 | Cap-Stik | Mcshane Medical, Inc. | FMI | Class II | |
| K926253 | Sudormed Sweat Patch Specimen Container: Cocaine | Sudormed, Inc. | JKA | Class II | |
| K952891 | Cronex Low Absorption Cassette | The du Pont Co. | IXA | Class II | |
| K952823 | Fhb, Fhb-T with or without Flextube Hfh, Hfh-T, Afa, Afh-T with or without Flexrtube | Icor AB | BYD | Class I | |
| K952784 | Oxboro-Medical Cautery Tip Cleaner | Oxboro Medical Intl., Inc. | HQP | Class II | |
| K952672 | Vertical Integrated Perfect View (Vip) Radiographic System | Bennett X-Ray Corp. | KPR | Class II | |
| K952534 | Tentatively Polarus Ex Rod | Acu Med, Inc. | HSB | Class II | |
| K951890 | Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac Troponin-I Calibrators | Dade Intl., Inc. | MMI | Class II | |
| K951888 | Dade Stratus Troponin-I Control | Dade Intl., Inc. | JJX | Class I |