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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable | Stryker Corp. | OWN | Class II | |
| K192269 | TwinScan 808/755 Laser System | Gme German Medical Engineering GmbH | GEX | Class II | |
| K192204 | Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, | Valencia Naturals, Inc | NUC | Class II | |
| K191278 | Rsi-MRI+ | Multimodal Imaging Services Corporation (dba Healthlytix) | LLZ | Class II | |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) | LHI | Class II | |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K192769 | Impella CP Introducer | Abiomed, Inc. | DYB | Class II | |
| K192323 | PolyLock Small Bone Plating System | Fusion Orthopedics, LLC | HRS | Class II | |
| K191980 | CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. | EBF | Class II | |
| K190797 | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | Reed Medical (Zhejiang) Co., Ltd. | HIH | Class II | |
| K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | FLL | Class II | |
| K182917 | FluoroCal | Bisco Inc | LBH | Class II | |
| K182732 | Jtl-250-01 | Jointechlabs, Inc | MUU | Class II | |
| K192937 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | JOJ | Class II | |
| K192940 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K192936 | Soltus 500 | Sedecal S.A. | IZL | Class II | |
| K192935 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | |
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | GGM | Class II | |
| K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | JXG | Class II | |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | PENTAX of America, Inc. | FDT | Class II | |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies ULC. (Now A Part of Stryker) | OWN | Class II | |
| K192113 | DRSplus | Centervue | MYC | Class II | |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | HQF | Class II | |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Cochlear Americas | PFO | Class II | |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | PIF | Class II | |
| K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | HBL | Class II | |
| K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | KWS | Class II | |
| K191201 | EM SA Implant System | Hiossen, Inc. | DZE | Class II | |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Immunalysis Corporation | QBK | Class II | |
| K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | HRS | Class II | |
| K190312 | Dornier Ureteral Stent | Dornier Medtech America, Inc. | FAD | Class II | |
| K183598 | KeyPrint KeySplint Soft | Keystone Industries | MQC | Unclassified | |
| K182672 | ROSA Bracket | Gni Co., Ltd. | NJM | Class II | |
| K192911 | Brainlab Compatible K2M Navigation Instruments | K2M, Inc | OLO | Class II | |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical Inc. | FDX | Class II | |
| K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K191280 | E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. | NAY | Class II | |
| K191110 | HeraBEAT™ US | Heramed Ltd. | KNG | Class II | |
| K190721 | LongBow Ti | Life Spine | MAX | Class II | |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) | Allwin Medical Devices, Inc. | MQF | Class II | |
| K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | Sterilmed Inc | OWQ | Class II | |
| K183666 | EBA One Nailing System | Citieffe Inc. | HSB | Class II | |
| K192915 | GMA 2.0 Pedicle Screw System | Grafton Medical Alliance | NKB | Class II | |
| K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | OVE | Class II | |
| K192469 | Nox Sleep System | Nox Medical | OLZ | Class II | |
| K192150 | AMICUS Separator System | Fresenius Kabi AB | LKN | Unclassified | |
| K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | FMI | Class II | |
| K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd | FLL | Class II | |
| K191477 | AEON-C Stand Alone System | Huvexel Co., Ltd. | OVE | Class II |