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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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

176,366 records, page 262 of 3528

510(k) clearances, page 262 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K214116	AAMI4 Isolation Gown	Hubei Xinxin Non-woven Co., Ltd	FYC	Class II	2022-10-11
K223008	Disposable Vinyl Examination Gloves	Jiangxi Handspro Products Solutions Co., Ltd.	LYZ	Class I	2022-10-08
K222714	Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs	Guangdong Kingfa Sci.&tech.co.,Ltd.	LZA	Class I	2022-10-07
K222698	CUVIS-spine	CUREXO, Inc.	OLO	Class II	2022-10-07
K222424	Protect-It Custom Fit Dental Guard	Doc Brands, Inc.	OBR	Unclassified	2022-10-07
K222418	Nuvola	Gruppo Europeo Ortodonzia SRL	NXC	Class II	2022-10-07
K222369	PURE Laser	Endymed Medical Inc.	GEX	Class II	2022-10-07
K222205	Cold Sore Device (Model: QPZ-01)	Light Tree Ventures Europe B.V.	OKJ	Class II	2022-10-07
K222028	IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System	Alphatec Spine, Inc.	MAX	Class II	2022-10-07
K221818	Rebellion; Phantom Multi-Bite Kerrison Rongeur	Morpheus AG	HAE	Class II	2022-10-07
K221764	InBody Blood pressure monitor, Model BPBIO480KV	InBody Co, Ltd.	DXN	Class II	2022-10-07
K221575	Pre-Formed Blue	Lake Region Medical	DQX	Class II	2022-10-07
K221498	Miha Bodytec II	Miha Bodytec GmbH	NGX	Class II	2022-10-07
K221492	SteriTite Container System with MediTray Parts	Case Medical, Inc.	KCT	Class II	2022-10-07
K221310	Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing	Changzhou Endoclean Medical Device Co., Ltd.	OCX	Class II	2022-10-07
K221170	Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107	Shenzhen AOJ Medical Technology Co., Ltd.	FLL	Class II	2022-10-07
K221154	Infant Heel WarmerTM; Heel Snuggler®	International Biomedical, Ltd.	MPO	Class I	2022-10-07
K220709	BriefCase	Aidoc Medical Ltd.	QAS	Class II	2022-10-07
K220267	AMSafe NeuFlo Needleless Connector	Amsino International, Inc.	FPA	Class II	2022-10-07
K220256	MIM-Ablation	MIM Software Inc	QTZ	Class II	2022-10-07
K220156	Electrically Powered Wheelchair, Joy Rider	Tung Keng Enterprise Co., Ltd.	ITI	Class II	2022-10-07
K220111	RespiraSense	Pmd Solutions	BZQ	Class II	2022-10-07
K220092	YADU Surgical Gowns	Henan Yadu Industrial Co.,Ltd	FYA	Class II	2022-10-07
K220057	Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization	Shinva Ande Healthcare Apparatus Co., Ltd.	MEG	Class II	2022-10-07
K213969	VisionAir Patient-Specific Airway Stent	New Cos Inc. dba Visionair Solutions	NWA	Class II	2022-10-07
K213610	Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps	Katalyst Surgical, LLC	GEI	Class II	2022-10-07
K213061	SuperCheck Pro Blood Glucose Monitoring System	OK Biotech Co., Ltd.	NBW	Class II	2022-10-07
K202163	Mico One Orthodontic Screw	ZE Fang Technology Co., Ltd.	OAT	Class II	2022-10-07
K222700	Tibial baseplate, Tibial insert	United Orthopedic Corp.	JWH	Class II	2022-10-06
K222686	Perfit FS Dental Zirconia Fully Sintered Block	Vatech Acucera, Inc.	EIH	Class II	2022-10-06
K222431	b-ONER MOBIO Total Knee System	b-ONE Ortho Corp.	JWH	Class II	2022-10-06
K222427	PRIMA TT Glenoid	Lima Corporate S.p.A.	MBF	Class II	2022-10-06
K222080	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile	SG Healthcare Co Ltd	OWB	Class II	2022-10-06
K221889	ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring	Prosomnus Sleep Technologies	LRK	Class II	2022-10-06
K221653	InfaTherm Disposable Infant Warming Mattress	International Biomedical, Ltd.	IMD	Class I	2022-10-06
K221449	Genius AI Detection 2.0	Hologic, Inc.	QDQ	Class II	2022-10-06
K220852	iCare IC200	Icare Finland Oy	HKY	Class II	2022-10-06
K220365	Gemini Sterilization Wrap	MEDLINE INDUSTRIES, LP - Northfield	FRG	Class II	2022-10-06
K213666	NuCath Wedge Pressure Catheter	PFM Medical GmbH	DQO	Class II	2022-10-06
K212168	A&D Medical UM-212BLE Blood Pressure Monitor	A&D Company, Ltd.	DXN	Class II	2022-10-06
K211892	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	Arftx Medical, LLC	MQP	Class II	2022-10-06
K222737	Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)	Shanghai AnQing Medical Instrument Co., Ltd	FGB	Class II	2022-10-05
K222515	FaSet Fixation System	Dio Medical Co., Ltd.	MRW	Unclassified	2022-10-05
K221892	Visionair	Pacificmd Biotech, LLC	BXQ	Class II	2022-10-05
K221759	Cornisol	Aurolab	LYX	Unclassified	2022-10-05
K221128	Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II	Arthrex GmbH	MAI	Class II	2022-10-05
K220546	Colibrí System	Copan WASP	LON	Class II	2022-10-05
K220140	ClearCorrect System	ClearCorrect, LLC	NXC	Class II	2022-10-05
K220138	Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP	Led SpA	GEI	Class II	2022-10-05
K212779	Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing	Coagusense Inc	GJS	Class II	2022-10-05