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 357 of 3528

510(k) clearances, page 357 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202424	Surgical Mask-Models CR02-2, CR02	Foshan Xinbao Technology Co., Ltd.	FXX	Class II	2021-03-31
K201879	Digital Thermometer Model T103, T104	Bioland Technology Ltd.	FLL	Class II	2021-03-31
K200502	Myriad Particles	AROA Biosurgery Inc.	KGN	Unclassified	2021-03-31
K210603	3M Bair Hugger Temperature Management System (Model 675)	3M Company	DWJ	Class II	2021-03-30
K210308	EMPOWR Porous Femur with HAnano SurfaceTM	Encore Medical, LP	MBH	Class II	2021-03-30
K210226	PicoSure Workstation	Cynosure, LLC	GEX	Class II	2021-03-30
K210058	Blue Nitrile Exam Glove, Powder Free	Great Harvest Trading Co., Ltd.	LZA	Class I	2021-03-30
K203836	BOMEDENT Apex locator, WISMY Apex locator	Changzhou Bomedent Medical Technology Co., Ltd	LQY	Unclassified	2021-03-30
K203641	E-Denture Pro	Envisiontec GmbH	EBI	Class II	2021-03-30
K202708	Surgical Face Masks	Intco Medical(Hk) Co., Ltd.	FXX	Class II	2021-03-30
K201896	ivi N3003 Surgical face Mask, ivi N6006 Surgical mask	Iob Medical, Inc.	FXX	Class II	2021-03-30
K201001	Modulith SLX-F2	Karl Storz Endoscopy-America, Inc.	LNS	Class II	2021-03-30
K210173	StarGuide	GE Healthcare	KPS	Class II	2021-03-29
K203827	Remi	Epitel	OMC	Class II	2021-03-29
K203826	LaserCap Family of Lasers 300, 224, 120 & 80	Transdermal Cap, Inc.	OAP	Class II	2021-03-29
K203505	DORO QR3 Headrest System (Aluminum)	Black Forest Medical GmbH	HBL	Class II	2021-03-29
K202191	Surgical Mask	Wuhan Zonsen Medical Products Co., Ltd	FXX	Class II	2021-03-29
K201590	EMMA Capnograph	Masimo Corporation	CCK	Class II	2021-03-29
K200601	LumiCare Caries Diagnostic Rinse	GreenMark Biomedical, Inc.	LFC	Class II	2021-03-29
K203417	Dvt-4000S	Daesung Maref Co.,Ltd	JOW	Class II	2021-03-28
K210638	i-ED COIL System	Kaneka Medical America LLC	HCG	Class II	2021-03-26
K210534	GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System	Gramercy Extremity Orthopedics, LLC.	HRS	Class II	2021-03-26
K210207	Humeral Eccentric Reverse Metaphysis	Medacta International SA	PHX	Class II	2021-03-26
K210205	DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System	Synthes (USA) Products LLC	HRS	Class II	2021-03-26
K203788	DermaV Laser System	Lutronic Corporation	GEX	Class II	2021-03-26
K203685	Disposable Surgical Face Mask	Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	FXX	Class II	2021-03-26
K203259	FairFix Adjustable Button System	Medacta International SA	MBI	Class II	2021-03-26
K203254	Lucent 3D Spinal System	Spinal Elements, Inc	MAX	Class II	2021-03-26
K203038	Toro-L Interbody Fusion System	Integrity Implants, Inc.	MAX	Class II	2021-03-26
K202905	Disposable Face Mask	Jiangsu Excellence Medical Supplies Co., Ltd	FXX	Class II	2021-03-26
K202751	TandemHeart Pump and Escort Controller	Cardiacassist, Inc.	QNR	Class II	2021-03-26
K202725	Etd4000	Therasigma, LLC	LIH	Class II	2021-03-26
K202547	Surgivisio system	Surgivisio	OWB	Class II	2021-03-26
K201957	A8, A9 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BSZ	Class II	2021-03-26
K201921	Spacelabs Lifescreen PRO Analyzer	GE Healthcare	DQK	Class II	2021-03-26
K201734	AllerBlock Junior	Nasaleze International, Ltd.	NUP	Class II	2021-03-26
K201634	RG 3ml Medication Cartridge	Chengdu Shifeng Medical Technology Co., Ltd.	MRZ	Class II	2021-03-26
K201466	Tranberg CLS Laser Applicator	Clinical Laserthermia Systems AB	GEX	Class II	2021-03-26
K201426	MyCRO Band	Otto Bock Healthcare LP	MVA	Class II	2021-03-26
K201197	TruAbutment DS, TruBase S	TruAbutment Inc.	NHA	Class II	2021-03-26
DEN200050	Portable Neuromodulation Stimulator (PoNS)	Helius Medical, Inc	QCF	Class II	2021-03-26
DEN200019	Oxehealth Vital Signs	Oxehealth Ltd	QME	Class II	2021-03-26
K210667	FIREBIRD SI Fusion System	Orthofix SRL	OUR	Class II	2021-03-25
K210566	LEGION Porous CR Narrow Femoral Components	Smith & Nephew, Inc.	MBH	Class II	2021-03-25
K210333	DiaPaste	Diadent Group International	KIF	Class II	2021-03-25
K203834	Arthrex Patella SuturePlates	Arthrex GmbH	HRS	Class II	2021-03-25
K203776	Surgical Masks, Model SNN200640 & MN112	Sq Medical Supplies, Inc.	FXX	Class II	2021-03-25
K203547	Nalu Neurostimulation System	Boston Scientific Neuromodulation Corporation	GZB	Class II	2021-03-25
K203273	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)	Echosens	IYO	Class II	2021-03-25
K202944	NEBULAE SRS Laparoscopic Surgical Smoke Removal System	Northgate Technologies Inc.	FYD	Class II	2021-03-25