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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 623 of 3529

510(k) clearances, page 623 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160924	Amendia Interbody Fusion Devices	Spinal Elements, Inc	MAX	Class II	2016-11-08
K162944	Irix-C Cervical Integrated Fusion System	Xtant Medical Holdings, Inc.	OVE	Class II	2016-11-07
K162863	dS Small Extremity 16CH 1.5T Coil	Invivo Therapeutics Corporation	MOS	Class II	2016-11-07
K162273	Materialise TKA Guide System	Materialise N.V.	JWH	Class II	2016-11-07
K162257	P1145 Dental Restorative	Sybron Dental Specialties, Inc.	EBF	Class II	2016-11-07
K162113	Powder Free Nitrile Examination Gloves (Blue)	Nam Viet Glove Joint Stock Company	LZA	Class I	2016-11-07
K161952	UltraShape System	Syneron Medical, Ltd.	OHV	Class II	2016-11-07
K161638	SPEEDTRAP Graft Preparation System	Medos International SARL	GAT	Class II	2016-11-07
K161624	MicrO2 OSA Device with Micro-Recorder	Microdental, Inc.	PLC	Class II	2016-11-07
K161254	Renovo Life Small Bone IM Nail System	Renovo Life, LLC	HSB	Class II	2016-11-07
K160446	MCP Bone Putty	Biostructures, LLC	MQV	Class II	2016-11-07
K162769	Pinpoint GT Introducer Needle	C.R. Bard Inc	DYB	Class II	2016-11-04
K162619	I View and Imagen Sensor	Trident SRL	MUH	Class II	2016-11-04
K162595	Trex_HD	Natus Medical Incorporated	GWQ	Class II	2016-11-04
K162585	SuniIQ Digital Radiography System	Suni Medical Imaging, Inc.	MUH	Class II	2016-11-04
K162573	Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source	Source Production and Equipment Co., Inc.	KXK	Class II	2016-11-04
K162440	CardioInsight Cardiac Mapping System	Cardioinsight Technologies, Inc.	DQK	Class II	2016-11-04
K162350	Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018	Boston Scientific Corporation	LIT	Class II	2016-11-04
K162284	Puritan Fecal Opti-Swab Collection and Transport System	Puritan Medical Products Company, LLC	JSM	Class I	2016-11-04
K162162	Barrier Supreme Sterilization Wrapper	Standard Textile Co., Inc.	FRG	Class II	2016-11-04
K161935	Avance Foam Dressing Kit - XL	Molnlycke Health Care, US LLC	OMP	Class II	2016-11-04
K161921	SwiftNINJA Microcatheter	Merit Medical Systems, Inc.	KRA	Class II	2016-11-04
K161913	AOS Small Fragment Plating System	Advanced Orthopaedic Solutions, Inc. (Aos)	HRS	Class II	2016-11-04
K161740	D-SPECT Scanner, D-SPECT L Scanner	Spectrum Dynamics Medical Inc.	KPS	Class II	2016-11-04
K161703	LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer	AAP Implantate AG	HRS	Class II	2016-11-04
K161646	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	Diazyme Laboratories, Inc.	CGN	Class II	2016-11-04
K161636	Lipogems System	Lipogems International S.p.A.	MUU	Class II	2016-11-04
K161357	LipiFlow Thermal Pulsation System	TearScience, Inc.	ORZ	Class II	2016-11-04
K160979	Inclusive Abutments	Prismatik Dentalcraft, Inc.	NHA	Class II	2016-11-04
K160361	PRIMAGARD Isolation Gown (AAMI PB70 Level 3)	Primed Medical Products Inc.	FYC	Class II	2016-11-04
K160278	VSTAAR AdjusteR	Spinal Acoustics, LLC	LXM	Unclassified	2016-11-04
K160153	Abl90 Flex Plus	Radiometer Medical ApS	CHL	Class II	2016-11-04
K162801	CastleLoc Spinal Fixation System	L&K Biomed Co.,Ltd.	MNH	Class II	2016-11-03
K162268	Senographe Pristina	GE Healthcare	MUE	Class II	2016-11-03
K162136	CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System	L&K Biomed Co.,Ltd.	NKG	Class II	2016-11-03
K161968	MicrUs	Telemed	IYO	Class II	2016-11-03
K161948	Avance Gauze Dressing Kits	Molnlycke Health Care, US LLC	OMP	Class II	2016-11-03
K161779	MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter	Medsource International, LLC	FOZ	Class II	2016-11-03
K161592	Persona Partial Knee System	Zimmer GmbH	HSX	Class II	2016-11-03
K161590	MatrixRIB Fixation System	Synthes (USA) Products LLC	HRS	Class II	2016-11-03
K161373	Nunchaku	Fci France Chirurgie Instrumentation	OKS	Unclassified	2016-11-03
K161174	Nanova Interference Screw	Nanova Biomaterials Inc	MAI	Class II	2016-11-03
K161157	Vitrea CT Dual Energy Image View	Canon Medical Informatics, Inc.	JAK	Class II	2016-11-03
K161131	FONA Pan/Ceph	Fona S.R.L	MUH	Class II	2016-11-03
K160921	CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant	CS Medical LLC	PSW	Class II	2016-11-03
K160532	Greiner Holdex	Greiner Bio-One Na, Inc.	FMI	Class II	2016-11-03
K160437	PleurX Peritoneal Catheter System	Care Fusion	PNG	Class II	2016-11-03
K160349	Electronic Sphygmomanometer	Guangdong Biolight Meditech Co., Ltd	DXN	Class II	2016-11-03
K160180	Intermittent Pneumatic Compression system	Daesung Maref Co.,Ltd	JOW	Class II	2016-11-03
K152615	Vonflex S	Vericom Co., Ltd.	ELW	Class II	2016-11-03