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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 996 of 3531

510(k) clearances, page 996 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102372	Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models Gbs-Dm, Gbs-Db	Jiangmen City Xinhui Baisheng Medical Equipment Co	GEI	Class II	2010-11-03
K102231	Discovery Nm 750B	GE Medical Systems Israel, Functional Imaging	IYX	Class I	2010-11-03
K102093	Powder Free Vinyl Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	LYZ	Class I	2010-11-03
K102072	Memometal Implants (K-Snap & Ti-Fuse)	Memometal Technologies	HTY	Class II	2010-11-03
K101882	Prontosan Antimicrobial Wound Gel	B.Braun Medical, Inc.	FRO	Unclassified	2010-11-03
K101182	Iolmaster 500	Carl Zeiss Meditec Inc	HJO	Class II	2010-11-03
K100917	Fidis Vasculitis Assay Kit and Analyzer and Caris System	Biomedical Diagnostics (Bmd) SA	MOB	Class II	2010-11-03
K100364	Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520	Gambro Renal Products	FJK	Class II	2010-11-03
K091360	Clearflux Dialyzer Reprocessing System	Novaflux Technologies	LIF	Class II	2010-11-03
K102583	Mucheck, Version 9.0	Oncology Data Systems, Inc.	IYE	Class II	2010-11-02
K102351	Grandio So	Voco GmbH	EBF	Class II	2010-11-02
K102074	Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, Blue (Sg)	Gx Corporation Sdn Bhd	LZA	Class I	2010-11-02
K102983	Vascuclear Precision Bipolar	LivaNova USA, Inc.	GEI	Class II	2010-11-01
K102086	Elecsys Ca 125 II Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-11-01
K092273	Randox Ethanol Assay	Randox Laboratories, Limited	DIC	Class II	2010-11-01
K103050	Dx-D 300	AGFA Healthcare Corp.	KPR	Class II	2010-10-29
K102906	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2010-10-29
K102905	Guided Medical Positioning System II (Gmps II)	Mediguide, Ltd.	DQK	Class II	2010-10-29
K102844	All-Bound 3	Bisco Inc	KLE	Class II	2010-10-29
K102655	Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera (Yellow, White, Blue)	Ever Light Plastic Products Co., Ltd.	LYZ	Class I	2010-10-29
K102575	Ortho Mta (Mineral Trioxide Aggregate)	Do Co., Ltd.	KIF	Class II	2010-10-29
K102423	Depuy Pinnacle Altrx Acetabular Liners	Depuy Orthopaedics Inc.	LPH	Class II	2010-10-29
K102347	Grandtec	Voco GmbH	EBI	Class II	2010-10-29
K102314	3M Integrated Cycler (110V) & (220V)	DiaSorin Molecular LLC	OOI	Class II	2010-10-29
K102013	Digital Retinal Camera	Canon Inc. -Medical Equipment Group	HKI	Class II	2010-10-29
K101961	Tigerpaw System	Laax, Inc.	GDW	Class II	2010-10-29
K101917	Comfort Rubber Gloves Ind.sdn.bhd.	Comfort Rubber Gloves Industries Sdn Bhd	LYY	Class I	2010-10-29
K101707	Fulaccess Model 1.0	Fulcrum Medical, Inc.	LLZ	Class II	2010-10-29
K101686	Fdr Image Stitching Option	FUJIFILM Healthcare Americas Corporation	KPR	Class II	2010-10-29
K101540	Granitec Dual-Cure Core Build-Up, N'durance Dimer Core	Novocol Inc. dba Septodont and Confi-Dental Produc	EBF	Class II	2010-10-29
K101504	Ti-Core Flow	Essential Dental Systems, Inc.	EMA	Class II	2010-10-29
K101437	Speedfix Suture System	ArthroCare Corporation	MBI	Class II	2010-10-29
K101305	Ark Lamotrigine Assay, Calibrator & Control	Ark Diagnostics Inc	ORH	Class II	2010-10-29
K101042	Bladeview	Accogent, LLC	KPR	Class II	2010-10-29
K101035	Wmi Reprocessed Dvt Wrap, Wmi Reprocessed Thermal Wrap Model: Rd-1000F, Rd-1000C, Rt 2000A, Rt 2000B, Rt 2000Kf, Rt 2000	Wmi Enterprises, LLC	JOW	Class II	2010-10-29
K100926	Arrowhead Fixation Device	Arrow Products, Inc.	HTY	Class II	2010-10-29
K100589	Mrsa Select - Skin and Soft Tissue Wound Specimens	Bio-Rad	JSO	Class II	2010-10-29
K092896	Rempress and Angiography Contrast Delivery System Rempress	Nemoto Kyorindo Co., Ltd.	DXT	Class II	2010-10-29
K092477	NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701	Neurowave Systems Inc.	OMC	Class II	2010-10-29
K092451	Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger, Intersurgical Inter-Guard Breathing Filter	Intersurgical Ltd.	CAH	Class II	2010-10-29
K102138	Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler	Edan Instruments, Inc.	MAA	Class II	2010-10-28
K101545	Genesis Implant System	Keystone Dental Inc.	DZE	Class II	2010-10-28
K101123	Nexfin Model 2	Bmeye B.V.	DXN	Class II	2010-10-28
K100574	Collexa	Innocoll Pharmaceuticals	KGN	Unclassified	2010-10-28
K100456	Cvue Advanced Definitive	Unilens Corp., USA	LPL	Class II	2010-10-28
K100443	Definitive, Flexlens - Silicone Hydrogel	X-Cel Contacts	LPL	Class II	2010-10-28
K100244	Metro Soft	Metro Optics of Austin, Inc.	LPL	Class II	2010-10-28
K102901	Hi Vision Avius Diagnostic Ultrasound Scanner	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2010-10-27
K102545	Fm-02 Bone Graft Substitute	DSM Biomedical, Inc.	MQV	Class II	2010-10-27
K102538	Ziecon Disc with Collar for Cad/cam Model Zd810-26, Ziecon Block for Mom Model Zb763812-20, Zb653012-21, Zb402012-20, Zi	Jyoti Ceramic Industries Private Limited	EIH	Class II	2010-10-27