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 |
|---|---|---|---|---|---|
| K190027 | SteriStay | Toul Meditech AB | ORC | Class II | |
| K183583 | Vanguard Complete Knee System | Zimmer GmbH | JWH | Class II | |
| K183319 | Triangle System | AliveCor | DXH | Class II | |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | MQE | Class II | |
| K182612 | Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) | Zibo Yahao Supplies Co., Ltd. | LZA | Class I | |
| K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd | HIH | Class II | |
| K190948 | Magic Clear Aligners | Voodoo Manufacturing, Inc. | NXC | Class II | |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | MLR | Class II | |
| K190699 | Rowheels Revolution 1.0 | Rowheels, Inc. | IOR | Class I | |
| K190666 | CYGNUS™ Anterior Cervical Plate System | Mirus, LLC | KWQ | Class II | |
| K190393 | Wingman 14C Crossing Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | HEB | Class II | |
| K183310 | Encore System | Siesta Medical, Inc. | ORY | Class II | |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | PDQ | Class II | |
| K181933 | DePuy Synthes Sterilization Container System | Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc. | KCT | Class II | |
| K181894 | TOF-Cuff monitor | Rgb Medical Devices SA | DXN | Class II | |
| K181491 | Delta Dual Mobility System | Lima Corporate S.p.A. | LZO | Class II | |
| K190567 | KeYi Spinal Fixation System | Beijing Keyi Medical Device Technology Co., Ltd. | NKB | Class II | |
| K190223 | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | PMN | Class II | |
| K190187 | Gynescope System | Illumigyn Ltd. | HEX | Class II | |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | MQP | Class II | |
| K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International | MAX | Class II | |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | GBM | Class II | |
| K183443 | SomnoDent Avant | Somnomed Inc. | LRK | Class II | |
| K183126 | Electrosurgical accessory | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | HMD Biomedical, Inc. | NBW | Class II | |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | OWQ | Class II | |
| K191011 | Scope ProTech | Meditech Endoscopy Ltd | OCU | Class II | |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | FUJIFILM Corporation | FDF | Class II | |
| K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray | Gebauer Co | MLY | Unclassified | |
| K183701 | Stryker ChestShield Sterilization Tray System | Paragon Medical Inc. | KCT | Class II | |
| K183512 | Moore Park Mask | ResMed Corp | BZD | Class II | |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics GmbH | JIL | Class II | |
| K183016 | SteriCap Mini Needle | Ocujet, LLC | FMI | Class II | |
| K182865 | Neodent Instruments Kits | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K181854 | OssBuilder System | OSSTEM Implant Co., Ltd. | DZL | Class II | |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. | DYB | Class II | |
| K190900 | Biograph Vision | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K190643 | Medline Electrocautery Pencil | MEDLINE INDUSTRIES, LP - Northfield | GEI | Class II | |
| K190362 | HealthPNX | Zebra Medical Vision, Ltd. | QFM | Class II | |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | Deka Research & Development Corp. | FRN | Class II | |
| K190165 | Capstone Control™ Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K190159 | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | LZC | Class I | |
| K182460 | MD-6000P Bladder Scanner | Meda Co., Ltd. | IYO | Class II | |
| K182437 | Wireless Intelligent Thermometer | Shenzhen Jumper Medical Equipment Co.,Ltd. | FLL | Class II | |
| K183577 | Medline Quick-Clear Wand | MEDLINE INDUSTRIES, LP - Northfield | KNT | Class II | |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products Limited | DFH | Class II | |
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC. | KXE | Class II | |
| K190532 | TruDi NAV Wire | Acclarent Inc | PGW | Class II |