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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 667 of 3530

510(k) clearances, page 667 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K153247	Fusion Compact Navigation System	Medtronic Navigation, Inc	PGW	Class II	2016-02-18
K153216	Alpine Cemented Hip System	Ortho Development Corp.	JDI	Class II	2016-02-18
K152902	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2016-02-18
K152702	ENT Biotech Solutions Tissue Removal Device (Elasso)	Ent Biotech Solutions	GEI	Class II	2016-02-18
K152648	Ennova Self-adhesive Electrode	Suzhou Ennova Electronics Technology Co.,Ltd	GXY	Class II	2016-02-18
K152196	Erchonia EVRL	Erchonia Corporation	NHN	Class II	2016-02-18
K152136	Recovery Cone Removal System	C.R. Bard Inc	MMX	Class II	2016-02-18
K151945	Triumph Resin Dam	Denali Corporation	EIE	Class I	2016-02-18
K151817	VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL	bioMerieux, Inc.	NGZ	Class II	2016-02-18
K151474	Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)	FUJIFILM Healthcare Americas Corporation	KGE	Class II	2016-02-18
K151258	Arm automatic blood pressure monitor	Shenzhen Pump Medical System Co., Ltd.	DXN	Class II	2016-02-18
K143290	DBSWIN and VistaEasy Imaging Software	Durr Dental AG	LLZ	Class II	2016-02-18
K160113	ST AIA-PACK hsE2 Calibrator Set	Tosoh Bioscience Inc	JIT	Class II	2016-02-17
K153593	CliniscanSM MRI	Picofemto, LLC	LLZ	Class II	2016-02-17
K153224	VitalStim(R) Plus Electrotherapy System	DJO, LLC	IPF	Class II	2016-02-17
K153095	ROP Resorbable Hemostasis Material	Resorbable Orthopedic Products, LLC	MTJ	Unclassified	2016-02-17
K152422	FREND™ Free T4 Test System	Nanoentek USA, Inc.	CEC	Class II	2016-02-17
K151165	Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture	Aesculap Inc	GAR	Class II	2016-02-17
K153647	TSolution One w/ACG+ Surgical System	Think Surgical Inc.	OLO	Class II	2016-02-16
K153631	Zimmer Virage OCT Spinal Fixation System	Zimmer Spine, Inc.	NKG	Class II	2016-02-16
K153523	FUSION Vascular Graft	Maquet Cardiovascular LLC	DSY	Class II	2016-02-16
K153479	NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System	Ninepoint Medical, Inc.	NQQ	Class II	2016-02-16
K153370	Caspian OCT/MESA Mini/DENALI Mini Spinal System	K2m, Incorporated	NKG	Class II	2016-02-16
K153368	Radiance V3	Gmv Soluciones Globales Internet S.A.U.	MUJ	Class II	2016-02-16
K152485	FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm	Verge Medical Inc.	LOX	Class II	2016-02-16
K152343	Direct Bilirubin	Randox Laboratories, Limited	JFM	Class II	2016-02-16
K151580	D.N.E. External Fixation System	Dne, LLC	KTT	Class II	2016-02-16
K150157	AnapnoGuard 100 Respiratory Guard System	Hospitech Respiration	BSK	Class II	2016-02-16
K153081	Clear Bi-Light	Michael Todd, LP	OLP	Class II	2016-02-15
K152596	Intact® Gen2 System	Intact Medical Corporation	KNW	Class II	2016-02-15
K151512	Star 60	Skanray Technologies Private Limited	MWI	Class II	2016-02-14
K160092	Digital Electrocardiograph	Shenzhen Biocare Bio-Medical Equipment Co., Ltd.	DPS	Class II	2016-02-12
K160001	TraumaCad Mobile Release 2.0	Voyant Health, Ltd.	LLZ	Class II	2016-02-12
K153718	Spirit Hair Removal laser Family	Active Optical Systems, Ltd.	GEX	Class II	2016-02-12
K153625	Single Use Injector NM600/610	Olympus Medical Systems Corp.	FBK	Class II	2016-02-12
K153608	Vitoss BiModal Bone Graft Substitute Foam Strip	DSM Biomedical, Inc.	MQV	Class II	2016-02-12
K153543	WHILL Model M	Whill, Inc.	ITI	Class II	2016-02-12
K153341	Relieva Scout Multi-Sinus Dilation System	Acclarent Inc	LRC	Class I	2016-02-12
K153309	BD Vacutainer UltraTouch Push Button Blood Collection Set	Becton Dickinson & Co	JKA	Class II	2016-02-12
K153307	HS SutureTape	Riverpoint Medical, LLC	GAT	Class II	2016-02-12
K153246	PTFE Super Sheath Introducer 2.1	Medcomp ( Medical Components)	DYB	Class II	2016-02-12
K153218	Arthrex Synergy UHD4 System	Arthrex GmbH	GCJ	Class II	2016-02-12
K153103	CARESTREAM Vue PACS	Eastman Kodak Company	LLZ	Class II	2016-02-12
K153077	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2016-02-12
K153004	Clear Guide SCENERGY	Clear Guide Medical	JAK	Class II	2016-02-12
K152781	Adena-Zina System	Shanghai Sanyou Medical Co. Ltd	NKB	Class II	2016-02-12
K152231	Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire	Boston Scientific Corporation	DQX	Class II	2016-02-12
K152187	MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws	Merete GmbH	HWC	Class II	2016-02-12
K151680	Powder Free Nitrile Patient Examination Gloves, Blue Color	Suqian Xingye Glove Co,Ltd	LZA	Class I	2016-02-12
K151644	Masimo Root Vital Signs Monitoring System and Accessories	Masimo Corporation	MWI	Class II	2016-02-12