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 2026-10-15, 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 360 of 3528

510(k) clearances, page 360 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192649	Endo Motor	Foshan CICADA Dental Instrument Co., Ltd.	EKX	Class I	2021-03-12
K210392	WorkMate Claris System	Abbott Medical	DQK	Class II	2021-03-11
K210142	Fiber Dust	Quanta System Inc.	GEX	Class II	2021-03-11
K210078	Stryker ProCinch Adjustable Loop Device	Stryker Corp.	MBI	Class II	2021-03-11
K203614	Monarch Bronchoscope	Auris Health, Inc., A Johnson and Johnson Family Company	QNW	Class II	2021-03-11
K202961	AquaBeam Robotic System	PROCEPT BioRobotics Corporation	PZP	Class II	2021-03-11
K202443	Smart Kit Basic, Smart Kit Pro	Bsl Co.	MUU	Class II	2021-03-11
K202062	wheezo WheezeRate Detector	Respiri Limited	PHZ	Class II	2021-03-11
K201975	miha bodytec II	Miha Bodytec GmbH	NGX	Class II	2021-03-11
K201892	Ritleng®+ and Ritleng®+ PVP	Fci (France Chirurgie Instrumentation) SAS	OKS	Unclassified	2021-03-11
K210359	Hexanium TLIF	Spinevision SAS	MAX	Class II	2021-03-10
K210164	Vantage Elan 1.5T, MRT-2020, V6.0	Canon Medical Systems Corporation	LNH	Class II	2021-03-10
K203606	Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)	Meris Investment Group	LRK	Class II	2021-03-10
K203574	HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2	Hivox Biotek Inc.	NUH	Class II	2021-03-10
K203065	Lumbar Spine Truss System Plating Solution (LSTS-PS)	4WEB Inc.	KWQ	Class II	2021-03-10
K202815	PROPHECY Preoperative Navigation Alignment System	Wrightmedicaltechnologyinc	HSN	Class II	2021-03-10
K202548	Surgical Face Mask	Wanxinda (Guangzhou) Technology Product Co., Ltd.	FXX	Class II	2021-03-10
K202411	Surgical Mask	Allmed Medical Products Co., Ltd.	FXX	Class II	2021-03-10
K202161	Surgical Face Mask	Hunan Eexi Technology & Service Co., Ltd.	FXX	Class II	2021-03-10
K201866	NovaLine Tubing Sets for Hemodialysis	Bain Medical Equipment(guangzhou) Co., Ltd.	FJK	Class II	2021-03-10
K201809	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory	Baxter Healthcare Corportation	KDI	Class II	2021-03-10
K201492	Non-Sterile Zirconia Block	Bioden Co., Ltd.	EIH	Class II	2021-03-10
K193663	FloPump 57mL Centrifugal Pump	International Biophysics Corp.	KFM	Class II	2021-03-10
K210181	Nordiwell Surgical Face Mask	Changzhou Combat Protective Equipment Co., Ltd.	FXX	Class II	2021-03-09
K203618	Neodent EasyGuide Kit Cases	JJGC Industria e Comercio de Materiais Dentarios SA	KCT	Class II	2021-03-09
K203600	VersaWrap	Alafair Biosciences, Inc.	FTM	Class II	2021-03-09
K203518	Quicktome	Omniscient Neurotechnology Pty Ltd (O8T)	LLZ	Class II	2021-03-09
K203256	Imbio RV/LV Software	Imbio, Inc.	QIH	Class II	2021-03-09
K202891	Blood Pressure Monitor	Guangdong Transtek Medical Electronics Co.,Ltd	DXN	Class II	2021-03-09
K202710	Disposable Medical Face Mask	Wanxinda (Guangzhou) Technology Product Co., Ltd.	FXX	Class II	2021-03-09
K202591	Body Infrared Thermometer HT-820D	Dongguan Xintai Instrument Co., Ltd.	FLL	Class II	2021-03-09
K202409	Surgical Mask	Allmed Medical Products Co., Ltd.	FXX	Class II	2021-03-09
K202375	ZOLL Propaq M	ZOLL Medical Corporation	MWI	Class II	2021-03-09
K202205	Surgical Face Mask	Jiangsu Micsafe Medical Technology Co., Ltd	FXX	Class II	2021-03-09
K201508	Infrared Thermometer	Dongguan Prestige Sporting Goods Co., Ltd.	FLL	Class II	2021-03-09
K203351	Perfit ZR HT Dental Zirconia blank	Vatech Acucera, Inc.	EIH	Class II	2021-03-08
K202753	iHealth Wireless No-Touch Forehead Thermometer	Andon Health Co., Ltd	FLL	Class II	2021-03-08
K202439	Disposable Medical Face Mask	Hunan Eexi Technology & Service Co., Ltd.	FXX	Class II	2021-03-08
K201728	Versalock Periprosthetic Femur Plates System-GMReis	GM dos Reis Industria e Comercio Ltda	HRS	Class II	2021-03-08
K201678	iCE-SG Subcutaneous Electrode Arrays	Ice Neurosystems, Inc.	GZL	Class II	2021-03-08
K200660	Compressible Limb and Circulation Therapy System	Wonjin Mulsan Co., Ltd.	IRP	Class II	2021-03-08
K202125	Century Perfusion System	Century HLM, LLC	DTQ	Class II	2021-03-07
K201974	Single-use medical face mask	Guangdong Horigen Mother & Baby Products Co., Ltd.	FXX	Class II	2021-03-07
K210390	Apex 3D Total Ankle Replacement System	Paragon 28	HSN	Class II	2021-03-06
K201581	CPR Band	Credo	LIX	Class II	2021-03-06
K210328	SafeSept Blunt Needle	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2021-03-05
K210309	Cios Select (VA21) Flat Panel	Siemens Medical Solutions USA, Inc.	OWB	Class II	2021-03-05
K203425	Surgical Mask	Bdc Dental Corporation, Ltd.	FXX	Class II	2021-03-05
K203346	Oec 3D	GE Healthcare	OXO	Class II	2021-03-05
K203261	Reprocessed Inquiry Steerable Diagnostic EP Catheter	Innovative Health, LLC.	DRF	Class II	2021-03-05