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 |
|---|---|---|---|---|---|
| K090460 | Bonos Inject | Aap Biomaterials GmbH | NDN | Class II | |
| K090297 | Blueshine Gold Series | Blueshine SRL | GEX | Class II | |
| K083848 | Alma Lasers Soprano Xl Multi-Application Platform | Alma Lasers Ltd. | GEX | Class II | |
| K083841 | Adaptable Composite Resin Restorative Material | Dentsply International, Inc. | EBF | Class II | |
| K083595 | Ezlase | Biolase MG LLC | ILY | Class II | |
| K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses | Alcon Laboratories | LPL | Class II | |
| K082388 | Minicap Immunotyping, Model: 2300 | Sebia, Inc. | CFF | Class II | |
| K090244 | Swift Fx | ResMed Corp | BZD | Class II | |
| K090148 | Proguide Chronic Dialysis Catheter | Merit Medical Systems, Inc. | MSD | Class II | |
| K083672 | P.d Software | .Decimal, Inc. | MUJ | Class II | |
| K083534 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | DRT | Class II | |
| K090873 | I Open 0.5T | Beijing Wandong Medical Equipment Co., Ltd. | LNH | Class II | |
| K090357 | Hydroframe (Hes) | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K090350 | Extreme 4X4-X8 Power Wheelchair | Vestil Manufacturing Corp. | ITI | Class II | |
| K090189 | Antimicrobial Clave, Models Ag Clave, Ag Microclave | Abbott Medical | FPA | Class II | |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi Sutures | Linvatec Corporation | MAI | Class II | |
| K083519 | Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units | Covidien Lp, Formerly Registered AS United States | GDW | Class II | |
| K083349 | Blood Transfusion Set | Shan Dong Wei Gao Group Medical Polymer Products | BRZ | Class II | |
| K083191 | Detlogix Annuloplasty Ring, Model: 5100 | Edwards Lifesciences LLC | KRH | Class II | |
| K082759 | Elia Cenp Immunoassay, Elia U1rnp Immunoassay, Elia Sm Immunoassay, Elia Ro Immunoassay | Phadia AB | LKJ | Class II | |
| K082065 | Well Life Self Adhesive Electrode / Models: Cm, Fa, Pu and Sp | Well-Life Healthcare Limited | GXY | Class II | |
| K080561 | Vidas Ca 125 II Assay | bioMerieux, Inc. | LTK | Class II | |
| K090663 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | FAE | Class II | |
| K090065 | Aerochamber Mini Ventilation Chamber | Trudell Medical Intl. | CAF | Class II | |
| K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | MAX | Class II | |
| K090043 | Autosure Voice Blood Glucose Monitoring System, Model As90011f9 | Apex Biotechnology Corp. | CGA | Class II | |
| K090014 | Caremate Sphygmomanometer with Stethoscope | Caremate Medical Device Co., Ltd. | DXQ | Class II | |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan Imp440, Imp440 Module, Titan Suite | Interacoustics a/S | ETY | Class II | |
| K083705 | Bci Ww1020 Pulse Oximeter, Model Ww1020 | Abbott Medical | DQA | Class II | |
| K083012 | Papcone | Otto Bock Pur Life Science GmbH | HHT | Class II | |
| K082309 | Cambria | Seaspine, Inc. | ODP | Class II | |
| K090801 | Electronic House Call | Express MD Solutions, LLC | DRG | Class II | |
| K090620 | Quikclot Inteventional, Model P/n 182 | Z-Medica, LLC | QSY | Unclassified | |
| K090465 | Digdop Ultrasound System | The Newman Group, LLC | ITX | Class II | |
| K090253 | Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001 | Possis Medical, Inc. | QEZ | Class II | |
| K090057 | On-Call Plus Blood Glucose Monitoring System | Acon Laboratories, Inc. | NBW | Class II | |
| K083483 | Brainlab Hip Unlimited, Ci Hip Unlimited | Brainlab, Inc. | OLO | Class II | |
| K083284 | Piezosurgery Medical | Piezosurgery S.r.l. | JDX | Class II | |
| K083278 | Avc A/h5n1 Flu Test | Arbor Vita Corportation | OMS | Class II | |
| K083215 | Incisive Family of Inpulse Nd:yag Lasers | Incisive, LLC | GEX | Class II | |
| K083007 | Prowick | Arthrex GmbH | FRO | Unclassified | |
| K082951 | Immersion Hydrobath | Arjohuntleigh AB | ILJ | Class II | |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100 | Siemens Healthcare Diagnostics Inc. | DCF | Class II | |
| K090853 | Yield Tissue Sampler | Broncus Technologies, Inc. | EOQ | Class II | |
| K090723 | Hex-Lock Short Abutment, Model Sa341, Sa342, Sa451, Sa452, Sa561, Sa562 Short Healing Cap, Model Saheal4, Saheal5, | ZimVie US Corp LLC | NHA | Class II | |
| K090411 | Freedom Metal Backed Tibial Component | Maxx Orthopedics Inc. | JWH | Class II | |
| K090316 | Modification to: Lanx Anterior Cervical Plate System | Lanx, Inc. | KWQ | Class II | |
| K090087 | Mridium 3860 MRI Infusion Pump/monitoring System | Iradimed Corporation | FRN | Class II | |
| K083809 | Creatinine | Abbott Medical | CGX | Class II | |
| K083627 | Wallflex Biliary Rx Fully-Covered Stent System, Model M00570500,m00570510, M00570520, M00570530, M00570540 | Boston Scientific Corporation | FGE | Class II |