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 |
|---|---|---|---|---|---|
| K020539 | Tipower Powerdrive and Rimpower X & Sx | TiSport, LLC | ITI | Class II | |
| K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | MNI | Class II | |
| K013962 | Equation Fixation System | Medtronic Sofamor Danek | MNH | Class II | |
| K021886 | Olympus Ultrasonic Gastrovideoscope Gf Type Uc140p-Do5 & Olympus Ultrasonic Gastrofiberscope Gf Type Uc30p | Olympus Optical Co., Ltd. | FDS | Class II | |
| K021861 | Remstar Pro with C-Flex CPAP System | Respironics, Inc. | BZD | Class II | |
| K021811 | Unidrive II Plus Disposable Tubing Set | Mtp Medical Technical Promotion GmbH | ERL | Class II | |
| K021640 | Hansatome Excellus Microkeratome | Bausch & Lomb Incorporated | HNO | Class I | |
| K021567 | Stimucath Continuous Nerve Block Set, Product Number Ab-05000 | Arrow Intl., Inc. | CAZ | Class II | |
| K021298 | Elements Diagnostic Unit | Sybron Endo/Analytic | EAT | Class II | |
| K021089 | Oximax Max-Fast Adhesive Forehead Sensor | Medtronic, Inc. | DQA | Class II | |
| K021017 | Leespec Disposable Vaginal Speculum | Itl Corporation Pty, Ltd. | HIB | Class II | |
| K020959 | Glo-Spec I, II and III | Sol Weiss MD, Inc. | HIB | Class II | |
| K020941 | Palomar Luxg Handpiece | Palomar | GEX | Class II | |
| K020560 | Workbench by <Genx> | <Genx> Intl., Inc. | MQG | Class II | |
| K020329 | Devilbiss Pd1000 | Sunrise Medical Hhg, Inc. | NFB | Class II | |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) Ddp-100; Battery Pack 1200Mah; Ba | Defibtech LLC | MKJ | Class III | |
| K011592 | Oxygen Treatment Hood | Amron International Diving Supply, Inc. | CBF | Class II | |
| K010156 | Sleep Pat 200 Device | Itamar Medical (C.M.) 1997, Ltd. | MNR | Class II | |
| K021680 | Invacare Powered Wheelchairs, Models M50, M51, M71 & M91 | Invacare GmbH | ITI | Class II | |
| K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International Inc | DLJ | Class II | |
| K021100 | 300 Pv Complete Electrotherapy System | Empi | IPF | Class II | |
| K021066 | Modification to Hyperglide Occlusion Balloon System | Medtronic, Inc. | MJN | Class II | |
| K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corporation | GAT | Class II | |
| K021009 | Octafix Occipital Cervical Plating System | Spinal Concepts, Inc. | KWP | Class II | |
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330 | Olympic Medical Corp. | OMC | Class II | |
| K011676 | Vivawave Microwave System | Vivant Medical, Inc. | NEY | Class II | |
| K021823 | Cardiospect D90/cardio Cam | Nuclear Cardiology Systems, Inc. | KPS | Class II | |
| K021423 | Instant-View Fecal Occult Blood Rapid Test | Alfa Scientific Designs, Inc. | KHE | Class II | |
| K021252 | Blood-Pressure Meter | Idt Technology Limited | DXN | Class II | |
| K021181 | Microscan Microstrep Plus Panel New Anticrobial-Clarithromycin | Dade Microscan, Inc. | JWY | Class II | |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric Analyser | The Binding Site | DFZ | Class II | |
| K021016 | Amx-4 Plus Mobile X-Ray System | GE Healthcare | IZL | Class II | |
| K020891 | Nakao Snare II and Nakao Snare III | Granit Medical Innovations | FDI | Class II | |
| K021866 | Karma 800 Series Manual Wheelchair | Vestil Manufacturing Corp. | IOR | Class I | |
| K021605 | Medgem | Healthetech, Inc. | BZL | Class II | |
| K021586 | Secure Reline/pickup Material | Imtec Corp. | EBI | Class II | |
| K021484 | Hemoglobin A1c Control | Canterbury Scientific Ltd. | LCP | Class II | |
| K021441 | Radius Snare | Radius Medical Technologies, Inc. | MMX | Class II | |
| K020915 | Sopro Light Sources and Accessories | Sopro | GCJ | Class II | |
| K020907 | Neuroline, Subdermal Needle Electrodes | Medicotest, Inc. | IKT | Class II | |
| K020896 | Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene | Osypka Medical GmbH | DTE | Class II | |
| K020857 | Eecp Therapy System Model Ts3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp Mc-2 External Counter | Vasomedical, Inc. | DRN | Class II | |
| K014113 | Endomap | Siemens Medical Solutions USA, Inc. | HAW | Class II | |
| K013977 | Echo-Screen T, Ta, Td, Tda, Tc | Fischer-Zoth Audiologic Systems, Inc. | GWJ | Class II | |
| K013297 | Aircast, Model #3011 | Millenium Reprocessing Services, Inc. | JOW | Class II | |
| K021763 | Rs2mi Muscle Stimulator Family | RS Medical | IPF | Class II | |
| K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4 | Nuclear Diagnostics, Inc. | KPS | Class II | |
| K021632 | Gp General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking Pigtail; Gp General Purpose Drainage C | Uresil, LLC | GBO | Class I | |
| K021593 | Modification to Envoy and Vista Brite Tip | Cordis US Corp. | DQY | Class II | |
| K021433 | Model 415Ph-64/42: Phased Array Shoulder Coil | Medical Advances, Inc. | MOS | Class II |