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 |
|---|---|---|---|---|---|
| K003187 | Vacucath i.v. Catheter Introducter | Auto/Cath Vascular Access, Inc. | FOZ | Class II | |
| K002043 | Pelvex Hometrainer | Purdue Technology Park | HIR | Class II | |
| K000733 | Quanta Lite Asca (S. Cerevisiae) Iga Elisa | Inova Diagnostics, Inc. | NBT | Class II | |
| K011385 | Hardkydisk Neomycin, 30 Mcg | Hardy Diagnostics | JTN | Class II | |
| K011233 | Modification to Glucosure Bgm System, Model 221100 | Apex Biotechnology Corp. | CGA | Class II | |
| K011219 | Ascent Knee System | Zimmer GmbH | JWH | Class II | |
| K011188 | Ge Logiq 9, Model 2188900-X | GE Healthcare | IYN | Class II | |
| K011169 | Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3 | International Enzymes, Inc. | JJY | Class I | |
| K010978 | Tina-Quant Alpha-1 Antitrypsin | Rochdiag | DEM | Class II | |
| K010958 | Fistulok Fistula Needle Protection | Diasol, Inc | FMI | Class II | |
| K010710 | Seedling Enterprises Llc, Cool Tec Monopolar and Bipolar Reusable Electrodes | Seedling Enterprises., LLC | GEI | Class II | |
| K010690 | Synthes Titanium Multi-Vector Distractor | Synthes (USA) Products LLC | DZL | Class II | |
| K010689 | Megabeam/ceralas Non Sterile Fiber Optic Laser Delivery Systems, Model 200,320,400 or 600Um | Biolitec, Inc. | GEX | Class II | |
| K010672 | Monograms Synthetic Monofilament Absorbable Suture | Gramsmed, LLC | GAM | Class II | |
| K010644 | Cinch-Type Disposable Limb Holders, Model 912025 | Skil-Care Corp. | FMQ | Class I | |
| K010517 | Advanta Sst Graft (<6Mm) | Atrium Medical Corporation | DSY | Class II | |
| K010516 | Advanta Sst Graft (>_6Mm) | Atrium Medical Corporation | DSY | Class II | |
| K010485 | Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech Lp Cave Filter | Bbraun | DTK | Class II | |
| K010162 | Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 | Medtronic, Inc. | MJN | Class II | |
| K003828 | Vaso Press Dvt Foot Garment #Vp 520 | Britt Corp., Inc. | JOW | Class II | |
| K002948 | K-Assay D-Dimer with Calibrator Set and Calibrator Diluent | Kamiya Biomedical Company, LLC | DAP | Class II | |
| K011347 | Emit 2000 Phenytoin Assay, Model 0Sr4a229 | Syva Co. | DIP | Class II | |
| K011300 | Emit II Plus Cannabinoid Assay, Model Osr9n229 | Syva Co., Dade Behring, Inc. | LDJ | Class II | |
| K011198 | Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental | Maxxim Medical | LZA | Class I | |
| K011167 | Xse | 3M Company | KLE | Class II | |
| K011064 | Classic Cem | S & C Polymer GmbH | EMA | Class II | |
| K010620 | Endoscopic Staple Removal Instrument | Onux Medical, Inc. | GCJ | Class II | |
| K010551 | Ebi Dynafix Vs Osteotomy System | Ebi, LLC | NDF | Class II | |
| K010464 | Radcalc, Model V.4.0 | Lifeline Software, Inc. | IYE | Class II | |
| K010177 | Visualine II (Also Known as Sunline) Amphetamine Assay | Sun Biomedical Laboratories, Inc. | DKZ | Class II | |
| K010101 | Gem Posterior Stabilized Total Knee System | Kinamed Inc | JWH | Class II | |
| K003486 | Stereotactic Frame Based System | Stryker Corp. | HAW | Class II | |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0Sr9f229 | Syva Co., Dade Behring, Inc. | JXM | Class II | |
| K011286 | Powder-Free Nitrile Exam Glove, Blue | Ningbo Yujiang Plastic & Rubber Co., Ltd. | LZA | Class I | |
| K011218 | Acumatch L-Series Cemented Femoral Stem, Model Size 1 | Exactech, Inc. | JDI | Class II | |
| K011217 | Clear or Braided Contrast Media Injection Line with or without Rotator, Cath Lab Kit | Abbott Medical | DQO | Class II | |
| K011213 | Modification to Synchron Lx 20 Clinical Chemistry System | Siemens Healthcare Diagnostics Inc. | JGS | Class II | |
| K011182 | Modified Moss Miami 4.35Mm Diameter Polyaxial Screws | Depuyacromed | MNH | Class II | |
| K011160 | E-Z Em Percupump 2001 CT Injector | E-Z-EM, Inc | JAK | Class II | |
| K011154 | Elipar Freelight | Espe Dental AG | EBZ | Class II | |
| K011079 | K-Assay Hs-Crp Controls | Kamiya Biomedical Company, LLC | DCK | Class II | |
| K010881 | Uniglove Polymer Coated Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | N.S. Uni-Gloves Sdn. Bhd. | LYY | Class I | |
| K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, Mdl-7609, Mem-7612, Opc-830 | Western Ent. | NFB | Class II | |
| K010730 | Modification to Flow 7000 Peripheral Vascular Coil | GE Healthcare Coils | MOS | Class II | |
| K010659 | Sea-Long Medical Treatment Hood | Sea-Long Medical Systems, LLC | CBF | Class II | |
| K010587 | Activeecg | Active Corp. | DRT | Class II | |
| K010510 | Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1 | A & A Medical, Inc. | HET | Class II | |
| K010466 | Tether Acfs | Theken Surgical,Llc | KWQ | Class II | |
| K010448 | Horizons International Varices Injection Needles | Horizons Intl. Corp. | FBK | Class II | |
| K003880 | Concentroc Hd Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) | Concentric Medical, Inc. | DQY | Class II |