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 632 of 3529

510(k) clearances, page 632 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160341	Colposcope System	Xuzhou Kernel Medical Equipment Co Ltd	HEX	Class II	2016-09-14
K153723	ACTICOAT Surgical Dressing	Smith & Nephew Medical Ltd	FRO	Unclassified	2016-09-14
K153676	Osteon III	GENOSS Co., Ltd.	LYC	Class II	2016-09-14
K153660	StealthStation System with Cranial Software	Medtronic Navigation, Inc	HAW	Class II	2016-09-14
K153311	Flexitouch System	Tactile Systems Technology, Inc. (dba Tactile Medical)	PPS	Class II	2016-09-14
K161551	Tr-100	BTL Industries, Inc	PBX	Class II	2016-09-13
K161263	OptoMonitor II	Opsens Inc.	DXO	Class II	2016-09-13
K153771	TXM Guiding Sheath	Texasmedical Technologies, Inc.	DYB	Class II	2016-09-13
K153130	Initial LiSi Block	GC America Inc.	EIH	Class II	2016-09-13
K161888	JULIET® LL Lateral Lumbar Cage	Spineart SA	MAX	Class II	2016-09-12
K161043	Profound System	Syneron Candela Corporation	PBX	Class II	2016-09-12
K160867	Pavati Z40.2 Zirconia	Ccri, Inc.	EIH	Class II	2016-09-12
K160221	Implance Dental Implant System, Implance Dental Abutment System	Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.	DZE	Class II	2016-09-12
K161519	NeuroStar TMS Therapy System	Neuronetics Inc.	OBP	Class II	2016-09-11
K162228	TorqVue Low Profile Delivery Catheter	Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor	DQY	Class II	2016-09-09
K161915	Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2016-09-09
K161876	Tritium® Sternal Cable Plate System	Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)	JDQ	Class II	2016-09-09
K161581	Arthrex Synergy RF System	Arthrex GmbH	GEI	Class II	2016-09-09
K161487	VPAP Adapt SV, VPAP Tx, S9 VPAP Tx	ResMed Corp	MNS	Class II	2016-09-09
K161356	Matrix LS-40 CO2 Laser System	Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	GEX	Class II	2016-09-09
K161201	ClearRead CT	Riverain Technologies	OEB	Class II	2016-09-09
K161187	EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs	Eco Medi Glove Sdn Bhd	LZA	Class I	2016-09-09
K161051	All-Bond Universal w/BAC (not finalized)	Bisco Inc	KLE	Class II	2016-09-09
K161004	Self-retaining Retractor	Fetzer Medical GmbH & Co.KG	GZT	Class II	2016-09-09
K160822	S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV	ResMed Corp	BZD	Class II	2016-09-09
K160754	Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)	Venclose, Inc.	GEI	Class II	2016-09-09
K160554	Enseal X1 Large Jaw Tissue Sealer	Ethicon Endo-Surgery Inc	GEI	Class II	2016-09-09
K160117	AbClose - Port Site Closure Device	Medeon Biodesign, Inc.	OCW	Class II	2016-09-09
K153701	ULYSS Multi View Sinuscope	Sopro-Comeg GmbH	EOB	Class II	2016-09-09
K153636	Liberator Powered Wheelchair with Solar Companion	Solar Mobilityllc	ITI	Class II	2016-09-09
K152879	Sure-Fine Insulin Syringes	Shina Med Corporation	FMF	Class II	2016-09-09
K151839	AMC Health VitalCaregiving System	Amc Health	MWI	Class II	2016-09-09
K162337	Symbia 6.5	Siemens Medical Solutions USA, Inc.	KPS	Class II	2016-09-08
K162288	SonoSite iViz Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2016-09-08
K161966	PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector	Revvity Health Sciences, Inc.	MQB	Class II	2016-09-08
K161895	2MP Color LCD Monitor CCL214 (CL21214)	JVCKENWOOD Corporation	PGY	Class II	2016-09-08
K161866	BioFlo Midline Catheter	Boston Scientific Corporation	FOZ	Class II	2016-09-08
K161535	SeaSpine® NewPort™ Spinal System	SeaSpine Orthopedics Corporation	NKB	Class II	2016-09-08
K161406	Navident	ClaroNav Inc.	PLV	Class II	2016-09-08
K161166	StageOne Select Cement Spacer Molds for Temporary Hip Replacement	Zimmer GmbH	MBB	Class II	2016-09-08
K161129	Pillar Sa Ptc	Orthofix SRL	OVD	Class II	2016-09-08
K160958	Battalion Universal Spacer System	Alphatec Spine, Inc.	PHM	Class II	2016-09-08
K160493	Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm	Salvin Dental Specialties, LLC	NPK	Class II	2016-09-08
K153609	RTS Flexible 1 MPJ Implant w/Grommets	In2bones USA, LLC	KWH	Class II	2016-09-08
K153387	Luna CPAP and Auto CPAP System	3B Medical Inc	BZD	Class II	2016-09-08
K153302	coflex-IF	Paradigm Spine GmbH	PEK	Class II	2016-09-08
K142846	Bbx1, Bbx2, Bbx1mo, Bbx1mc	Globaldental, Inc.	DZE	Class II	2016-09-08
K162222	GENflex2 Total Knee System	Globus Medical, Inc.	JWH	Class II	2016-09-07
K161758	Weck Auto Endo10 Automatic Endoscopic Clip Applier	Teleflex Medical	FZP	Class II	2016-09-07
K161744	Symmetry Sharp Kerrison Rongeur	Symmetry Surgical GmbH	HAE	Class II	2016-09-07