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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | Cook Incorporated | NHC | Class II | |
| K160093 | RayStation | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear | Interojo Inc. | LPL | Class II | |
| K153639 | OneQ-SL s-Clean Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K153622 | First Ray Internal Bone Staple System | First Ray, LLC | JDR | Class II | |
| K153581 | Bladder Scanner | Caresono Technology Co.,Ltd. | IYO | Class II | |
| K153464 | FDR D-EVO flat Panel Detector System | FUJIFILM Healthcare Americas Corporation | MQB | Class II | |
| K153446 | OLYMPIC Posterior Spinal Fixation System | Astura Medical | OSH | Class II | |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | Philips North America LLC | JAK | Class II | |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | Dentalez, Inc. | EFB | Class I | |
| K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear | Eyeyon Medical | LPL | Class II | |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics GmbH | KXT | Class II | |
| K153098 | Klockner Vega Dental Implant System | Soadco, S.L. | DZE | Class II | |
| K153084 | Nephros S100 | Nephros Inc | NHV | Class II | |
| K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | GEI | Class II | |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corp. | DSI | Class II | |
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | OLY | Class II | |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical Ltd. | DZE | Class II | |
| K143612 | LifeCare PCA Infusion System | Abbott Medical | MEA | Class II | |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | MOF | Class II | |
| K160651 | BD FlowSmart Set, MiniMed Pro-Set | Becton Dickinson & Co | FPA | Class II | |
| K160355 | Cx20n(cx20pux) | Wide Corporation | PGY | Class II | |
| K160351 | Cx50n, Cx50yqs | Wide Corporation | PGY | Class II | |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | Beijing East Whale Imaging Technology Co., Ltd. | IYN | Class II | |
| K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc | PGW | Class II | |
| K153163 | ReGrasp | Rehabtronics, Inc. | GZI | Class II | |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | MTD | Class II | |
| K152864 | Merge Hemo | Merge Healthcare Incorporated | DQK | Class II | |
| K152700 | StrataMR Valves and Shunts | Medtronic Neurosurgery | JXG | Class II | |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corp. | KWY | Class II | |
| K152194 | transGlide Expandable Introducer | Transaortic Medical, Inc. | DYB | Class II | |
| K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | Sugentech, Inc. | LCX | Class II | |
| DEN150028 | PneumoLiner | Advanced Surgical Concepts | PMU | Class II | |
| K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.p.A. | KWS | Class II | |
| K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | PLK | Class II | |
| K153566 | Magma System | Formatk Systems Ltd. | GEX | Class II | |
| K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | HRS | Class II | |
| K153293 | Extension Set | B.Braun Medical, Inc. | FPA | Class II | |
| K151983 | KLS Martin LSS Plating System | KLS-Martin L.P. | JDQ | Class II | |
| K160734 | SonoSite SII Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K160368 | EVO platform | Quanta System Inc. | GEX | Class II | |
| K160360 | Barrx FLEX RFA Energy Generator | Medtronic, Inc. | GEI | Class II | |
| K160160 | Non-Telescopic PenEvac | I.C. Medical, Inc. | GEI | Class II | |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | Surgical Instrument Service and Savings (dba Medline Renewal | NLM | Class II | |
| K153009 | ULTRA Telescopes | Olympus Winter & Ibe GmbH | EOB | Class II | |
| K152947 | Disposable Temporary Pacing Cable | Tiger Medical Products, Ltd. | DSA | Class II | |
| K152652 | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement | Gaia Dental Products, Inc. | EMA | Class II | |
| K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | Circadiance | BZD | Class II | |
| K151503 | Nutricare-Isosaf Naso-Gastric Feeding Tube | Gbuk Enteral Limited | PIF | Class II |