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 |
|---|---|---|---|---|---|
| K050538 | Imc Drapes | Intl. Medsurg Connection, Inc. | KKX | Class II | |
| K050486 | Protect Tooth Desensitizer | Sunstar Butler | LBH | Class II | |
| K050371 | Medrad Vanguard Dx Angiographic Catheter | Medrad, Inc. | DQO | Class II | |
| K050277 | Chlorinated Powder Free Latex Examination Gloves (Yellow) | Hartalega Sdn Bhd | LYY | Class I | |
| K031196 | Surgetics Ortho Kneelogics Navigation System | Praxim S.A | HAW | Class II | |
| K051094 | Nuzone X2t Polychloroprene Synthetic Tan Surgical Glove - Powderfree | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K051074 | Mas Immunosuppressant Controls | Microgenics Corporation | LAS | Class I | |
| K051043 | Vanguard Reprocessed Diagnostic Electrophysiology Catheters | Stryker Sustainability Solutions | NLH | Class II | |
| K050918 | Koo Americas Valve PEEP, Model Km-809 | Koo Americas, Inc. | BYE | Class II | |
| K050790 | Spotchem II Ldh Test | Arkray, Inc. | CFH | Class II | |
| K050776 | Auss-6 Ultrasonic Surgical Aspirator System | Misonix, LLC | LFL | Unclassified | |
| K050713 | Duet Hs-Crp Lit Assay, Catalog Number: 4010, Duet Hs-Crp Calibrator Set, Catalog Number: 4511 | Good Biotech Corp. | DCN | Class II | |
| K050243 | Immedia Prothrombin Time System | Farallon Medial, Inc. | JPA | Class II | |
| K050082 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | NQW | Class II | |
| K043558 | Xinfeng Heat Lamps, Models, Cq-27,Cq-36, Cq-55, Cq-55A | Chongqing Xinfeng Medical Instruments Co., Ltd. | ILY | Class II | |
| K043358 | Reprocessed Ultrasonic Scalpels | Alliance Medical Corp. | NLQ | Unclassified | |
| K043306 | Skylark Infrared Photon Stimulator, Models, Sd-956Ir and Sd-100Ir | Skylark Device & Systems Co., Ltd. | ILY | Class II | |
| K043296 | Colactive Ag Collagen with Silver Antimicrobial Dressing | Covalontechnologies, Inc. | FRO | Unclassified | |
| K051334 | Terason Ultrasound System with Continuous Wave Soppler | Teratech Corp. | IYN | Class II | |
| K051304 | Iscience Surgical Ophthalmic Imaging System | Science Surgical Corporation | IYO | Class II | |
| K051152 | Powdered Vinyl Patient Examination Gloves, White (Non-Colored) | Zibo Sinocare Plastic Products Co., Ltd. | LYZ | Class I | |
| K051138 | Bd Phoenix Automated Microbiology System - Ceftriaxone (Strep) 0.0625 - 4Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K051127 | Kika Imaging Lab Viewer, Model 2.0.1.0 | Kika Medical, Inc. | LLZ | Class II | |
| K051123 | Callos Impact and Inject Bone Void Filler | Skeletal Kinetics, LLC | MQV | Class II | |
| K050885 | Olympus Ultrasonic Surgical System Sonosurg | Olympus Medical Systems Corp. | LFL | Unclassified | |
| K050870 | Riva Light Cure | Southern Dental Industries, Inc. | EMA | Class II | |
| K050795 | Imbibe Bone Marrow Aspiration Needle | DSM Biomedical, Inc. | KNW | Class II | |
| K050734 | Cool.click | Bioject, Inc. | KZE | Class II | |
| K050599 | Tracker Excel -14 Pre-Shaped Microcatheter | Boston Scientific Corporation | DQY | Class II | |
| K050008 | Mentor Self-Cath Hydrogel Intermittent Catheter | Mentor | EZD | Class II | |
| K043574 | Allient Sorbent Hemodialysis System, Model 1000 | Renal Solutions, Inc. | FKT | Class II | |
| K043050 | Hemcon Bandage and Hemcon Bandage OTC | Hemcon, Inc. | QSY | Unclassified | |
| K041514 | Truesilk Non-Absorbable Silk Surgical Suture | Sutures India Private Limited | GAP | Class II | |
| K041511 | Trulene Non-Absorbable Polypropylene Surgical Suture | Sutures India Private Limited | GAW | Class II | |
| K041096 | Wagner Steriset Sterilization Container | Wagner GmbH | FRG | Class II | |
| K033591 | Reprocessed Trocars | Clearmedical, Inc. | KBG | Class I | |
| K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model Ace23p, Ace36p | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K050738 | Ft Fiber Optic Delivery Systems | Fibertech Co., Ltd. | GEX | Class II | |
| K050438 | Stealthstation System Update | Medtronic Navigation, Inc | HAW | Class II | |
| K043340 | Ez Smart | Vip Diagnostics, LLC | NBW | Class II | |
| K041512 | Nonabsorbable (Polyethylene Terephthalate) Surgical Suture | Sutures India Private Limited | GAT | Class II | |
| K041510 | Trulon Non-Absorbable Polyamide Surgical Suture | Sutures India Private Limited | GAR | Class II | |
| K051308 | Mylab 70 Ultrasound Imaging System | Esaote S.p.A. | IYN | Class II | |
| K051258 | Kodak Directview Dr 7500 System, Model 8791345 | Eastman Kodak Company | KPR | Class II | |
| K051167 | Revolix and Revolix Jr | Allmed Systems, Inc. | GEX | Class II | |
| K051133 | Arcadis Avantic | Siemens Medical Solutions USA, Inc. | OXO | Class II | |
| K051107 | Onyx II Finger Pulse Oximeter, Model 9550 | Nonin Medical, Inc | DQA | Class II | |
| K051022 | Gammaplan | Elekta Instrument AB | IWB | Class II | |
| K050947 | Modification to: Modified Uss Polypropylene Suture | United States Surgical, A Division of Tyco Healthc | GAW | Class II | |
| K050925 | Digital Radiography System Radspeed Safire | Shimadzu Corp. | MQB | Class II |