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 |
|---|---|---|---|---|---|
| K230758 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K230479 | ComASP Cefiderocol 0.008-128 | Liofilchem S.r.l. | JWY | Class II | |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation | OBJ | Class II | |
| K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | GEI | Class II | |
| K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | |
| K223725 | Restrata® MiniMatrix | Acera Surgical, Inc. C/O Linda Braddon, PhD | QSZ | Unclassified | |
| K223645 | I.V. Administration Set, I.V. Extension Set | BQ Plus Medical Co., Ltd. | FPA | Class II | |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | AD-Tech Medical Instrument Corp. | GZL | Class II | |
| K223269 | Spencer Probe Depth Electrodes | AD-Tech Medical Instrument Corp. | GZL | Class II | |
| K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | KKX | Class II | |
| K222356 | Claritag Advanced | Dgi Technologies | GEH | Class II | |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | EKX | Class I | |
| DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | QWH | Class II | |
| K231128 | JuggerKnot Soft Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K231102 | Symbia Pro.specta VA20A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | PSN | Class II | |
| K230286 | Assert-IQ™ Insertable Cardiac Monitor | Abbott Medical | MXC | Class II | |
| K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | MUJ | Class II | |
| K230358 | SAVI Dual (TM) Migraine Therapy | eNeura Inc | OKP | Class II | |
| K230262 | BruxZir™ Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine | MAX | Class II | |
| K223893 | Infrared Heat (Model: E0221) | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | ITH | Class II | |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | HIF | Class II | |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Hologic, Inc. | QOF | Class II | |
| K222560 | BlueCheck™ Caries Detection & Monitoring | Incisive Technologies Pty Ltd | LFC | Class II | |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | Cook Incorporated | MMX | Class II | |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & Co. KGaA | CBK | Class II | |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & Co. KGaA | CBK | Class II | |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Ltd | FQH | Class II | |
| K231391 | Combi Touch | Mectron S.p.A. | ELC | Class II | |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn Bhd | LZA | Class I | |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Straumann USA, LLC | NHA | Class II | |
| K220526 | Hd+12, Hd+15 | Cardioline S.p.A. | DRG | Class II | |
| K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) | Mmj Labs, LLC | PHW | Class I | |
| K223147 | myLEDmask | Myblend | OHS | Class II | |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | KGO | Class I | |
| K223308 | Heating Tens/ems, Ft-810R | Hivox Biotek Inc. | NUH | Class II | |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | |
| K231190 | EPIQ Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | BTA | Class II | |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | KYF | Class II | |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | KYF | Class II | |
| K230684 | RadiForce MX217 | Eizo Corporation | PGY | Class II | |
| K230414 | ClariVy™ Cervical IBF System | VY Spine, LLC | ODP | Class II |