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 |
|---|---|---|---|---|---|
| K254214 | Ooopds | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | LLZ | Class II | |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | NKB | Class II | |
| K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | JTZ | Class II | |
| K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | QDQ | Class II | |
| K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | DTZ | Class II | |
| K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | NRY | Class II | |
| K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | EHD | Class II | |
| K260781 | Yumizen H550 | Horiba Abx Sas | GKZ | Class II | |
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | PKL | Class II | |
| K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K261287 | Digistat Care | Ascom Ums Srl Unipersonale | MSX | Class II | |
| K260133 | Caddie | Odin Medical Limited | QNP | Class II | |
| K262874 | CraniUS Plate | CraniUS, LLC | GWO | Class II | |
| K262861 | PureLift Pro Max | Xtreem Pulse, LLC | NFO | Class II | |
| K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | |
| K262397 | CuratOR EX2742 | Eizo Corporation | GCJ | Class II | |
| K262230 | Mg OSTEOREVIVE™;Mg OSTEOCRETE™ | Bone Solutions, Inc. | MQV | Class II | |
| K262151 | SpaceOAR Flex™ System | Boston Scientific Corporation | OVB | Class II | |
| K262050 | Vioseal X | Spident Co., Ltd. | KIF | Class II | |
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | OVD | Class II | |
| K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | QPC | Class II | |
| K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | QOF | Class II | |
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | JOW | Class II | |
| K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | MLO | Class II | |
| K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | OMP | Class II | |
| K261305 | Micsi-Pet | Microstructure Imaging, Inc. | KPS | Class II | |
| K261255 | Kowa Fm-600 | Kowa Company, Ltd. Chofu Factory | MYC | Class II | |
| K261019 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | |
| K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FED | Class II | |
| K260115 | DRIM-Nail System | 41Medical AG | |||
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | JWH | Class II | |
| K260001 | Mint ACE Pump | Beta Bionics, Inc. | QFG | Class II | |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | GEI | Class II | |
| K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | HBF | Class II | |
| K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | HBC | Class II | |
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | FPA | Class II | |
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | MWJ | Class II | |
| K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | KGI | Class II | |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | KRA | Class II | |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | FRO | Unclassified | |
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation | BTO | Class II | |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | |
| K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | JWH | Class II | |
| K262202 | Cerasmart Forte | GC America, Inc. | EBF | Class II | |
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | FET | Class II | |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | DXN | Class II | |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | QIH | Class II | |
| K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | GEX | Class II | |
| K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | NFT | Class II |