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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | NHN | Class II | |
| K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K180385 | Infrared Body Thermometer | Hetaida Technology Co., Ltd. | FLL | Class II | |
| K180383 | Light based hair removal device | Shenzhen GSD Tech Co., Ltd | OHT | Class II | |
| K180287 | GSI Corti | Grason-Stadler, Inc. | EWO | Class II | |
| K173264 | EmbryoScope+ | Vitrolife Inc. | MQG | Class II | |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | |
| K172719 | HealthBeacon HB2 Sharps Bin | Healthbeacon | MMK | Class II | |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | Nonin Medical, Inc | DQA | Class II | |
| K172570 | ALGS6 Ag Alginate Wound Dressing | Foshan United Medical Technologies Ltd. | FRO | Unclassified | |
| K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | OLO | Class II | |
| K172510 | µCor Heart Failure and Arrhythmia Management System | ZOLL Manufacturing Corporation | MHX | Class II | |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer | Foremount Enterprise Co., Ltd. | BTM | Class II | |
| K180961 | RadiForce MX194 | Eizo Corporation | PGY | Class II | |
| K180937 | Graftgun Universal Graft Delivery System | Surgentec LLC | FMF | Class II | |
| K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine | OVE | Class II | |
| K180625 | Rondek PGA Suture (Beige or Violet) | R.K. Manufacturing | GAM | Class II | |
| K180360 | OKTAGON Implant System | Hager & Meisinger GmbH | DZE | Class II | |
| K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | MAI | Class II | |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | MUD | Class II | |
| K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed | KCT | Class II | |
| K173012 | ANGIO-PRESS LITE DVT Compression Device | Pegasus Medical Supply, Inc. | JOW | Class II | |
| K172882 | Uincare Home | Uincare Corp. | LXJ | Class II | |
| K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | GMP Medicare Sdn Bhd(F25) | LZA | Class I | |
| K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics Corp | HSB | Class II | |
| K181032 | Halcyon | Varian Medical Systems, Inc. | IYE | Class II | |
| K180932 | Diamond Orthopedic Bone Fixation Screws and Pins | Diamond Orthopedic | HWC | Class II | |
| K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | LZO | Class II | |
| K180913 | VSI Micro-Introducer Kit | Vascular Solutions LLC | DYB | Class II | |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | IYN | Class II | |
| K180279 | Silk'n MODEL H5003 device | Home Skinovations, Ltd. | NGX | Class II | |
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation dba Dsm Biomedical | MQV | Class II | |
| K173452 | EmboTrap ll Revascularization Device | Neuravi Limited | NRY | Class II | |
| K173311 | ARTHRO-Pump PA304 | Novanta Medical GmbH | HRX | Class II | |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | MWP | Class II | |
| K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | Sekisui Medical Co., Ltd. | JPA | Class II | |
| K172191 | STERIZONE VP4 Sterilizer | Tso3, Inc. | PJJ | Class II | |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | Medela AG | OMP | Class II | |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Inc. | GEX | Class II | |
| K180386 | Meron Plus QM | Voco GmbH | EMA | Class II | |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube | Abbott Medical | JOH | Class II | |
| K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | HIH | Class II | |
| K173831 | Glidesheath Slender | Terumo Medical Corp. | DYB | Class II | |
| K173510 | BioStamp nPoint | Mc10, Inc. | DRG | Class II | |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | Centinel Spine, LLC | MAX | Class II | |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | FDS | Class II | |
| K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co.KG | HCZ | Class II | |
| K172484 | A-CIFT SoloFuse | SPINEFRONTIER, Inc. dba LESspine Innovations | OVE | Class II | |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems Inc | DEH | Class II |