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 |
|---|---|---|---|---|---|
| K070843 | Synthes Adolescent Lateral Entry Femoral Nail System | Synthes (USA) Products LLC | HSB | Class II | |
| K070750 | 247 Bp Device | Suntech Medical, Inc. | DXN | Class II | |
| K070726 | Nio Color 3Mp and Mdnc 3120 | Barcoview, Medical Imaging Systems | LLZ | Class II | |
| K070713 | Implant Location Software-T | Tactile Technologies, Ltd. | LLZ | Class II | |
| K070678 | Ddrcompact, Ddrcompact Plus and Ddrcompact Chest | Swissray International, Inc. | KPR | Class II | |
| K070446 | Cool-Tip Switching Controller, Ctsw Control | Valleylab,A Division of Tyco Healthcare Group LP | GEI | Class II | |
| K070388 | Profile Multi-Platform System | Sciton, Inc. | GEX | Class II | |
| K070353 | Kelsey Intersitital Laser Therapy System | Kelsey, Inc. | GEX | Class II | |
| K070307 | Steri -Mate Handpiece Sleeve with LED Light | Dentsply International, Inc. | ELC | Class II | |
| K070193 | Envitec Oxipen Pulse Oximeter and Accessories | Envitec-Wismar GmbH | DQA | Class II | |
| K063202 | Proderma Liquid Bandage | Procurement Technology Systems, LLC | KMF | Class I | |
| K052480 | Hansen Medical Catheter Control System (Ccs) and Accessories, Hansen Medical Steerable Guide Catheter (Sgc) and Sheath | Hansen Medical, Inc. | DXX | Class II | |
| K071081 | Contact Lens Case | Ningbo Kaida Rubber and Plastic Technology Co., LT | LRX | Class II | |
| K071028 | Viewmate System | Abbott Medical | ITN | Class I | |
| K070906 | Modificaton to: Zimmer Periarticular Locking Plates and Screws | Zimmer GmbH | HWC | Class II | |
| K070902 | Modification to: Ensite System, Model, Ee3000 | Abbott Medical | DQK | Class II | |
| K070893 | Cryospray Ablation System, Model Cu 8407020500 | CSA Medical | GEH | Class II | |
| K070752 | Ksea Miniature Endoscope, Model 11565 | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K070637 | Fluoroperm 92, 60, 30 and 151 and Paragon Hds, Hds 100 and Thin Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | HQD | Class II | |
| K070628 | Optimum Gp (Roflufocon A,b,c,d&e) Daily Wear Contact Lens. | Contamac Ltd. | HQD | Class II | |
| K070494 | Epi-C Plus | Espansione Marketing SpA | GEX | Class II | |
| K063137 | Pharmasmart Public Use Blood Pressure Monitor, Models Ps-1000/Ps-1500/Ps-2000 | Pharmasmart, Inc. | DXN | Class II | |
| K062731 | Ultrasonic Scaler, Varios 560 | Nakanishi Inc. | ELC | Class II | |
| K070772 | Pressx Zr | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K070714 | Medisize Gold Heater and Booster | Medisize BV | BTT | Class II | |
| K070552 | Dimension Vista Ferritin Flex Reagent Cartridge (Ferr) | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K070537 | Zirblock | Cdl Technologies, Inc. | EIH | Class II | |
| K070321 | Twilight Full Face Mask | Invacare GmbH | BZD | Class II | |
| K070251 | Carbon Dioxide Liquid Stable Reagent | Horiba Instruments Incorporated | KHS | Class II | |
| K070178 | Aesculap Resorbable Pin, Model Fr735 | Aesculap Implant System, Inc. | MAI | Class II | |
| K063659 | Easy Curing Pen-Style LED Curing Light | Dent Corp. Research & Development | EBZ | Class II | |
| K063341 | 3I Osseotite Certain Dental Implants | ZimVie US Corp LLC | DZE | Class II | |
| K063233 | Deltacut (Apparatus and Cannula) | Pajunk GmbH Medizintechnologie | KNW | Class II | |
| K062641 | Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-Av1 | Avazzia, Inc | GZJ | Class II | |
| K062538 | Easy Check Blood Glucose Monitoring System | Diacare Corp. | NBW | Class II | |
| K061849 | Mesoderm | Aa Advanced Technology, Inc. | EGJ | Class II | |
| K061632 | Globus Premium Muscle Stimulator | Domino S.r.l. | NGX | Class II | |
| K071019 | Digital Clinical Thermometer/models St8c Series | Mesure Technology Co., Ltd. | FLL | Class II | |
| K071011 | Modification to: Braemar Er900 Series Enhanced Algorithm ECG Event Recorder | Braemar Manufacturing, LLC | MWJ | Class II | |
| K070876 | Stryker Twist Drills | Stryker Craniomaxillofacial | HBE | Class II | |
| K070867 | Inomax Ds (Delivery System), Model 10003 | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K070512 | Modification to Aquadex Flexflow System | Chf Solutions, Inc. | KDI | Class II | |
| K070410 | Cook Microwire Wire Guide | Cook Inc. | DQX | Class II | |
| K070018 | Universal Surgical Mesh, Model 100 | Generic Medical Device, Inc. | FTL | Class II | |
| K063808 | Fraxel IV Sr Laser System | Reliant Technologies, Inc. | GEX | Class II | |
| K063783 | Philips Reusable Spo2 Sensors M1191t, M1192t and M1193t, Clip Sensor M1196t and Disposable Spo2 Sensors M1131a, M1132a | Philips North America LLC | DQA | Class II | |
| K063779 | Osseospeed 4.0S-6Mm, Model 24619 | Astra Tech, Inc. | DZE | Class II | |
| K063695 | Runthrough Ns | Terumo Medical Corp. | DQX | Class II | |
| K063503 | Optivantage Dh Injector System with Enhanced Communication | Mallinckrodt Inc., Liebel-Flarsheim Business | IZQ | Class II | |
| K063328 | Imc Heartway, Llc Electric Powered Wheelchair, Model Allure (Hp6) | Imc-Heart Way LLC | ITI | Class II |