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 |
|---|---|---|---|---|---|
| K222539 | Facet Blood Lancets | Facet Technologies, LLC. | QRL | Class II | |
| K222535 | OCS Lung Donor Flush Set | Transmedics, Inc. | MSB | Class II | |
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | BYI | Class II | |
| K222493 | CODA™ Anterior Cervical Plate System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | OAP | Class II | |
| K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K222189 | SiOxD Wound Matrix | SiOxMed, LLC | QSZ | Unclassified | |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | EOB | Class II | |
| K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | FAJ | Class II | |
| K221369 | FBCC Night Guard | Fbcc, Inc. | OBR | Unclassified | |
| K221330 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K220658 | COSY Cervicothoracic Occipital Rod-Screw System | Signus Medizintechnik GmbH | NKG | Class II | |
| K220351 | Polso Watch | Chronisense Medical, Ltd. | DQA | Class II | |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | Auxein medical Private Limited | MBI | Class II | |
| K212911 | Konig Mogen Clamp | MEDLINE INDUSTRIES, LP - Northfield | HFX | Class II | |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Sebia, Inc. | DFH | Class II | |
| K223278 | easy Claire | Y&j Bio Co., Ltd. | OHS | Class II | |
| K223267 | Skr 3000 | Konica Minolta, Inc. | MQB | Class II | |
| K223227 | MAVEN™ Patient-Specific Instrumentation | Paragon 28 | HSN | Class II | |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | Alphatec Spine, Inc. | ODP | Class II | |
| K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASE | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | GEX | Class II | |
| K222598 | IPL Hair Removal Device | Shenzhen Noble Smart Manufacturing Tech Co., Ltd. | OHT | Class II | |
| K222518 | FX Contra | Nakanishi Inc. | EGS | Class I | |
| K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | LLZ | Class II | |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D | Qingdao Hisense Medical Equipment Co.,Ltd. | PGY | Class II | |
| K222109 | Accure Laser | Accure Acne, Inc | GEX | Class II | |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus | ConvaTec Limited | EZD | Class II | |
| K221479 | Persona Personalized Knee System | Zimmer GmbH | JWH | Class II | |
| K221281 | Multitom Rax | Siemens Medical Solutions | OWB | Class II | |
| K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | FMI | Class II | |
| K220905 | xvision Spine System | Augmedics Ltd. | SBF | Class II | |
| K220820 | Parky App | H2o Bilisim Yazilim | GYD | Class II | |
| K220739 | Disposable Urine Collection Tube | Zhejiang Gongdong Medical Technology Co., Ltd | JSM | Class I | |
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | BRZ | Class II | |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | EBI | Class II | |
| K213295 | C.c. Life 21 | 21 Equipment S.r.l. | PBX | Class II | |
| K213042 | Supra Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | GEI | Class II | |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | EFB | Class I | |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | PDZ | Class II | |
| K222628 | Life Spine ALIF Buttress Plate System | Life Spine | KWQ | Class II | |
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | Xtrallux, LLC | OAP | Class II | |
| K221762 | BoneMRI v1.4 | Mrlguidance B.V. | QIH | Class II | |
| K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona Inc | DZE | Class II | |
| K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | Dentsply Sirona Inc | DZE | Class II | |
| K220635 | Heater-Cooler System 3T | LivaNova Deutschland GmbH | DWC | Class II | |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, LLC | CCK | Class II | |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | PENTAX of America, Inc. | EOB | Class II | |
| K220302 | Disposable surgical face mask | Shandong Aida Medical Products Co., Ltd. | FXX | Class II | |
| K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | FYA | Class II | |
| K203528 | KNH Surgical Face Mask | Knh Surgical Face Mask | FXX | Class II |