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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | FYA | Class II | |
| K240990 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K240094 | LumiNE US; Lumi | Augmedit | QIH | Class II | |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) | Medline ReNewal | OWQ | Class II | |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | MQB | Class II | |
| K242349 | FoLix | Lumenis Ltd | GEX | Class II | |
| K242042 | TriALTIS™ Spine System | Medos International SARL | NKB | Class II | |
| K241681 | Overjet Image Enhancement Assist | Overjet | QIH | Class II | |
| K241678 | TENS & EMS Stimulator (MHD-1083) | Shenzhen Minghuangda Electronics Co.,LTD | NUH | Class II | |
| K241205 | Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K240791 | Adas 3D | ADAS3D Medical S.L | QIH | Class II | |
| K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pty Ltd | QDQ | Class II | |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | SRI Trang Gloves (Thailand) Public Company Limited. | LYY | Class I | |
| K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt., Ltd. | NKB | Class II | |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical | LJS | Class II | |
| K242415 | TMC Compression Implant System | Treace Medical Concepts, Inc. | JDR | Class II | |
| K241976 | nextaro® va, 15mm, 5µm | SFM Medical Devices GmbH | LHI | Class II | |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250) | Femasys Inc. | LKF | Class II | |
| K241672 | Copro 3 | Amt Engineering Co., Ltd. | GEX | Class II | |
| K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH | EIH | Class II | |
| K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | Mentor Worldwide, LLC | MRD | Unclassified | |
| K241427 | Access Syphilis | Siemens Healthcare Diagnostics Inc. | LIP | Class II | |
| K241415 | Orchid Safety Release Valve™ | Linear Health Sciences LLC | QOI | Class II | |
| K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | MAX | Class II | |
| K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | DYB | Class II | |
| K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | QIH | Class II | |
| K234044 | ACS® LD FB Knee System | implantcast GmbH | JWH | Class II | |
| K234035 | COSINE™ Spacer | Globus Medical, Inc. | MAX | Class II | |
| K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi de CV | QIS | Class II | |
| K233921 | Luvis Chair (LC700C) | Dentis Co.,Ltd | KLC | Class I | |
| K233911 | VISULAS combi | Carl Zeiss Meditec Inc | HQF | Class II | |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | DRF | Class II | |
| K233806 | T2 Plus | OSSTEM Implant Co., Ltd. | OAS | Class II | |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO, Ltd. | MAX | Class II | |
| K232543 | Msc Sfm | Yocon Biology Technology Company | NDS | Class II | |
| K231667 | Withings Sleep Rx | Withings | MNR | Class II | |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | FRN | Class II | |
| K241723 | Electric wheelchair (W3902) | Zhejiang Richall Medical Technology Co., Ltd | ITI | Class II | |
| K241721 | Electric wheelchair (N3901) | Zhejiang Richall Medical Technology Co., Ltd | ITI | Class II | |
| K241605 | Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology | Nanovis, LLC | MAX | Class II | |
| K241356 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | HRS | Class II | |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | OKJ | Class II | |
| K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | Dyne Medical Group Inc. | FGB | Class II | |
| K233998 | TRAQinform IQ | Aiq Global, Inc. | LLZ | Class II | |
| K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | Intradin (Shanghai) Machinery Co., Ltd | INI | Class II | |
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | OUK | Class II | |
| K231566 | ICX-Implant System | Medentis Medical GmbH | DZE | Class II | |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | OMC | Class II | |
| K242305 | BE Plus PRO, Neurotravel LIGHT | EB Neuro S.p.A. | GWL | Class II | |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | EBI | Class II |