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 |
|---|---|---|---|---|---|
| K963329 | Ethicon Endosuture System | Ethicon, Inc | GCJ | Class II | |
| K963265 | Prosys Samec La | Convatec, A Division of E.R. Squibb & Sons | EXJ | Class I | |
| K963173 | Stealthstation System | Surgical Navigation Technologies, Inc. | HAW | Class II | |
| K963096 | Allevyn Hydro Poly Dressing Nd All Trac Dressing | Smith & Nephew United, Inc. | KMF | Class I | |
| K962948 | Ceralas G Nd;yag Laser System (Ceralas G) | Ceram Optec, Inc. | GEX | Class II | |
| K962938 | Excelsior Disposable Syringe W/normal Saline (.9% Sodium Chloride) | Excelsior Medical LLC | FOZ | Class II | |
| K962933 | Opart Mrt-600 | Toshiba America Mri, Inc. | LNH | Class II | |
| K962932 | Cordis Stabilizer Plus Xs | Cordis US Corp. | DQX | Class II | |
| K962925 | Olympus B-5/B-7 Seriesballoon Catheter | OLYMPUS Corporation of the Americas | FGE | Class II | |
| K962924 | Personal Best II with Zone Management System | Healthscan Products, Inc. | BZH | Class II | |
| K962865 | Rembrandt System | Airsep Corp. | FLS | Class II | |
| K962675 | Sta - Liatest Vwf Test Kit | American Bioproducts Co. | GJT | Class II | |
| K962225 | Viewsend Medical Model 1200 | Klt Telecom, Inc. | LMD | Class I | |
| K961418 | Osteomed Mss | Osteomed | DZL | Class II | |
| K960985 | Sls-CT | Bio-Imaging Research, Inc. | JAK | Class II | |
| K960571 | Rapid Electrophoresis Analyzer | Helena Laboratories, Corp. | JHO | Class I | |
| K960486 | Ksea Model 383320 20 Angiomat | Karl Storz Endoscopy-America, Inc. | DQI | Class II | |
| K960168 | Siemens Servo Screen 390 and Servo Computer Module 990 | Siemens Elema AB | CBK | Class II | |
| K960159 | Cordis Straight or Finned Ventr Cath (W/radio Dots) | Cordis US Corp. | JXG | Class II | |
| K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | CBK | Class II | |
| K953210 | Glucose (Hexokinase) Kit | Randox Laboratories, Limited | CFR | Class II | |
| K951567 | Cardiometics Flowire, Smartwire Doppler Guide Wire | Cardio Metrics, Inc. | ITX | Class II | |
| K963734 | Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry Systems | Alko Diagnostic Corp. | CGZ | Class II | |
| K963710 | Pacer Plus Synthetic Medical Vinyl Patient Examination Glove Powder Free | Canopus Medical Supply Co., Ltd. | LYZ | Class I | |
| K963684 | A2 Port, Dual Lumen System with Detached Catheter, Catalog # Ap-01518 (Modified) | Arrow Intl., Inc. | LJT | Class II | |
| K963664 | Dental Handpiece and Accessory | Filmtech | EFB | Class I | |
| K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) Module | Roche Diagnostic Systems, Inc. | JGS | Class II | |
| K963560 | Medi-Plus, Health-Plus, Sanitex, Reliance | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K963541 | Sigma Diagnostics CO2 Acid Reagent | Sigma Diagnostics, Inc. | JFL | Class II | |
| K963537 | Sigma Diagnostics Bun Reagent | Sigma Diagnostics, Inc. | LFP | Class II | |
| K963514 | Pacer Plus Synthetic Medical Vinly Patient Examination Gloves (Powdered) | Shanghai PM Plastics Enterise Co., Ltd. | LYZ | Class I | |
| K963209 | Prostyle Compact | Planmeca Oy | KLC | Class I | |
| K963110 | Jetlite | J. Morita USA, Inc. | EBZ | Class II | |
| K963107 | Etest for Cefepime | Ab Biodisk | JWY | Class II | |
| K962964 | Heelbo Johnny Grait Belt Security Belt | Hollister, Inc. | FMQ | Class I | |
| K962963 | Checkmate Ankle Restraint System | Hollister, Inc. | FMQ | Class I | |
| K962929 | Personal Best II | Healthscan Products, Inc. | BZH | Class II | |
| K962334 | Eml105 Electrolyte Metabolite Analyzer | Radiometer America, Inc | JGS | Class II | |
| K961864 | Csf/urine Total Protein | Teco Diagnostics | CEK | Class II | |
| K960367 | Incstar Rubella Igg Elisa Assay | Incstar Corp. | LFX | Class II | |
| K960358 | Incstar Rubella Igg Fast Elisa Assay | Incstar Corp. | LFX | Class II | |
| K955923 | Medi-Trace Combination Defibrillation & ECG Electrode for Laerdal | Graphic Controls Corp. | MKJ | Class III | |
| K955882 | Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators | Graphic Controls Corp. | MKJ | Class III | |
| K955553 | Perfecta Revision Hip System | Wrightmedicaltechnologyinc | LWJ | Class II | |
| K950686 | i.v. Start Kit | James J. Schramm | FMI | Class II | |
| K963772 | Somnus Model 225 Electro Surgical Generator (Model 225) | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K963301 | Standard Wheelchair | L & M Resource Information Service, Inc. | IOR | Class I | |
| K963227 | White Sun Light Source Model #: Xl300 and #: Xl175 | Products for Medicine | GCT | Class II | |
| K963222 | Microgyn Plus Stimulation Device | Hollister, Inc. | KPI | Class II | |
| K963213 | Boehringer Mannheim Direct Hdl-Cholesterol | Boehringer Mannheim Corp. | LBS | Class I |