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 |
|---|---|---|---|---|---|
| K242010 | Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) | Shenzhen Sanping Image Technology Co., Ltd. | EOQ | Class II | |
| K241960 | DeepRESP | Nox Medical Ehf | OLZ | Class II | |
| K241816 | VerteGlide Spinal Growth Guidance System | Orthopediatrics Corp | PGM | Class II | |
| K241765 | PLANET Onco Dose (3.2) | Dosisoft | LLZ | Class II | |
| K234012 | Vitek Compact Pro | bioMerieux, Inc. | LON | Class II | |
| K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics Corp. | MCW | Class II | |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics Inc. | JWH | Class II | |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical Oy | HBE | Class II | |
| K250255 | xvision Spine system | Augmedics Ltd. | SBF | Class II | |
| K250113 | neoLaser Laser Surgery Fibers | G.N.S Neolaser Ltd. | GEX | Class II | |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | QEW | Class II | |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics Inc | FTC | Class II | |
| K243993 | Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. | GEX | Class II | |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | GXY | Class II | |
| K243735 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | GEH | Class II | |
| K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | Unclassified | |
| K242406 | SiOxC Cream | SiOxMed, LLC | FRO | Unclassified | |
| K241811 | MedCAD® AccuStride™ System | MedCAD | PBF | Class II | |
| K250605 | EVOL® ha – Hyper C Cervical Interbody Fusion System | Cutting Edge Spine | ODP | Class II | |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik | GCJ | Class II | |
| K243957 | Picoalex | WONTECH Co., Ltd. | GEX | Class II | |
| K243903 | Rct600 | Ray Co., Ltd. | OAS | Class II | |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | MUE | Class II | |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | BioFire Defense, LLC | PRD | ||
| K243783 | Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co.,Ltd. | IPL | Class II | |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd | NGX | Class II | |
| K243746 | Delphi Amplifier | Quantalx Neroscience | GWL | Class II | |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. dba Lifeward | PHL | Class II | |
| K250424 | Arthrex TightRope Soft Button, RT | Arthrex GmbH | MBI | Class II | |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Corp. | HBE | Class II | |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | FRN | Class II | |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K242610 | 8mm Monopolar Curved Scissors (470179) | Iconocare Health | QSM | Class II | |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp | MYN | Class II | |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec (Pty) Ltd | OZT | Class II | |
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | KPJ | Class II | |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | MEH | Class II | |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | JXG | Class II | |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | GAG | Class II | |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | Medline ReNewal | OWQ | Class II | |
| K241944 | AGILON® XO Shoulder Replacement System | implantcast GmbH | KWT | Class II | |
| K243970 | Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd | ITI | Class II | |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | FLE | Class II | |
| K243798 | Orthex External Fixation System | Orthopediatrics Corp | KTT | Class II | |
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | HRS | Class II | |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai Seegen Photoelectric Technology Co., Ltd | FBN | Class II | |
| K243515 | EpiWatch Monitoring System | EpiWatch, Inc. | POS | Class II | |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | HIS | Class II | |
| K242914 | Op.n(TM) Navigation | Ecential Robotics | OLO | Class II |