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 |
|---|---|---|---|---|---|
| K131525 | Semiautomatic External Defibrillator and Accessories | Defibtech LLC | MKJ | Class III | |
| K130557 | Neuragen 3D | Integra LifeSciences Corporation | JXI | Class II | |
| K140561 | Axios Stent and Delivery System (with 10Mm X 10Mm Stent) Axios Stent and Delivery System (with 15Mm X 10Mm Stent) | Xlumena, Inc. | PCU | Class II | |
| K140445 | Dexis Software: Dexis Imaging Suite, Dexis Mac | Dental Imaging Technologies Corporation | LLZ | Class II | |
| K140010 | Fortress Pedicle Screw System | Spineology, Inc. | NKB | Class II | |
| K133897 | Tvc Imaging System, Tvc Insight Catheter | Nipro Vascular Innovations Americas, Inc. | OGZ | Class II | |
| K133758 | Centervue Macular Integrity Assessment | Centervue | HLI | Class II | |
| K133742 | Xq-1 Incubator | At Medical UAB | MQG | Class II | |
| K133009 | Nasal Mask, Nasal Mask, Full Face Mask | BMC Medical Co., Ltd. | BZD | Class II | |
| K132595 | Ontex Roll Wadding Plastic Applicator Compact Size Unscented Tampons | Ontex Bvba | HEB | Class II | |
| K132549 | Accutip Cover | Accutome, Inc. | HKY | Class II | |
| K132077 | Patient Monitor | Advanced Instrumentations, Inc. | MHX | Class II | |
| K131889 | Eum 100Pro | Promedic, Inc. | OSP | Class II | |
| K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60Mm, Standard, Echelon Flex Powered Plus Articulating | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K140442 | Medsource Selectable IV Set | Medsource International, LLC | LHI | Class II | |
| K140147 | Bct Antimicrobial Dressing & Bct Silver Bandage | Bio-Medical Carbon Technology Co., Ltd. | FRO | Unclassified | |
| K133829 | Aquabplus,aquabplus & Aquabplus B2,aquabplus&aquabplus Hf,aquabplus& Aquabplus B2& Aquablus HF | Vivonic GmbH | FIP | Class II | |
| K133761 | Aplio 500/400/300 Diagnostic Ultrasound System V4.0 | Toshibamedical Systems Corporation | IYN | Class II | |
| K133649 | Hepatic Vcar | GE Medical Systems SCS | JAK | Class II | |
| K132390 | Instinct; Plain, Dotted, Ultra Thin | Profilatex, S.A. de C.V. | HIS | Class II | |
| K140761 | Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian Cannula | Medtronic, Inc. | HES | Class II | |
| K140307 | Envoy Guiding Catheter | Cerenovus, Inc. | DQY | Class II | |
| K140303 | Alamo T | Alliance Partners, LLC | MAX | Class II | |
| K140625 | Orthosorb Ls | Zimmer GmbH | OVZ | Class II | |
| K140474 | Juliet Ol | Spineart SA | MAX | Class II | |
| K140375 | Mastergraft Putty, Mastergraft Strip | Medtronic Sofamor Danek USA Inc | MQV | Class II | |
| K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Spectranetics Corp. | PNO | Class II | |
| K133941 | Mitek Arthroscopes | Medos International SARL | HRX | Class II | |
| K133922 | Gentlecare Ar Applicator | GC Medtech, LLC | JAQ | Class II | |
| K133915 | Galaxy CO2 Laser System | Beijing Toplaser Technology Co., Ltd. | GEX | Class II | |
| K133624 | Compass CT, Compass CT Port | Mirador Biomedical, Inc. | DRS | Class II | |
| K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/tray | Cook Inc. | JOH | Class II | |
| K133534 | Mckesson Cardiology ECG Mobile | Change Healthcare Israel Ltd. | DQK | Class II | |
| K133397 | P-Pod | P-Pod | MVA | Class II | |
| K132679 | Af Viral/bacterial Filter, Bf Viral/bacterial Filter | Galemed Corp. | CAH | Class II | |
| K132406 | Elementv Blood Glucose Monitoring System | Infopia Co, Ltd. | NBW | Class II | |
| K132315 | Ergonomic Products Workstation | Ergonomic Products, Inc. | EIA | Class I | |
| K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) | Mindray North America | MHX | Class II | |
| K131612 | Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages | GS Medical Co., Ltd. | MAX | Class II | |
| K140808 | Q-Station | Philips North America LLC | LLZ | Class II | |
| K140769 | Variax 2 System | Stryker Trauma GmbH | HRS | Class II | |
| K140745 | Encore 26 Advantage Kit | Boston Scientific Corporation | MAV | Class II | |
| K140715 | Zip Mis Interspinous Fusion System | Aurora Spine, Inc. | PEK | Class II | |
| K140495 | Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode | Boston Scientific Corporation | GEI | Class II | |
| K140406 | Destino Twist, Steerable Guiding Sheath | Oscor Inc. | DYB | Class II | |
| K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | HRS | Class II | |
| K140321 | Initary Better Bladder-Pediatric | Circulatory Technology, Inc. | DTN | Class II | |
| K133823 | Nuface Mini Device | Carol Cole Company | NFO | Class II | |
| K133802 | Ais Modulift Vbr System | Aesculap Implant System, Inc. | MQP | Class II | |
| K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | JAK | Class II |