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 2480 of 3531

510(k) clearances, page 2480 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K905285	Ifsa Sterile Braided Poly Nonabsor Surg Sutures	Internacional Farmaceutica, S.A. de C.V.	GAS	Class II	1991-02-11
K905141	Centauri	Pfizer Laser Systems	HQF	Class II	1991-02-11
K905129	Baerveldt Glaucoma Implant	Wright Medical	KYF	Class II	1991-02-11
K905115	Biovision Endocular Probe	Douglas James Donaldson Compliance Services	HGF	Class II	1991-02-11
K905022	Aqua-Gard Waterproof Wound Patch	Bellhouse Medical, Inc.	KGX	Class I	1991-02-11
K904987	Vibronics Auto Core Biopsy Device (Acbd)	Vibronics	KNW	Class II	1991-02-11
K904558	Dual Lumen 5 Fr Perip Cent Ven Cath W/groshong Val	Davol, Inc.	FOZ	Class II	1991-02-11
K904418	Ultrasound Coupling Gel	Geno Laboratories	JOT	Class II	1991-02-11
K900694	Castable Abutments	Calcitek, Inc.	DZE	Class II	1991-02-11
K910155	Scimed Optamum Oper Peripheral Angioplasty Cath	Scimed Life Systems, Inc.	LIT	Class II	1991-02-07
K905853	Antimicrobial Susceptibility Test Panel	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1991-02-07
K905729	Canmed 451	Andover Medical, Inc.	DRX	Class II	1991-02-07
K905636	Ventrex Coated Tube Ige Enzyme Immunoassay	Ventrex Laboratories, Inc.	DHB	Class II	1991-02-07
K905458	Swan-Ganz(r) Flow Direct Oximetry/thermod Cather	Baxter Healthcare Corporation	DQE	Class II	1991-02-07
K905251	Mtp Transport Infusion Pump Model No. 1001A	Medical Technical Products, Inc	FRN	Class II	1991-02-07
K905159	Flo-Rester(r) Vessel Sizer	Bio-Vascular, Inc.	DWP	Class II	1991-02-07
K905072	Altair	Pfizer Laser Systems	GEX	Class II	1991-02-07
K905025	Digital Thermometer Kits	Abco Dealers, Inc.	FLL	Class II	1991-02-07
K904696	Wep-8430A Telemetry Central Station	Nihon Kohden America Inc	DRT	Class II	1991-02-07
K904689	Antimicrobial Suscept Test Panel/add Antibiotics	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1991-02-07
K904079	Bard Uterine Manipulator	C.R. Bard Inc	LKF	Class II	1991-02-07
K904027	Abbott Vision(tm) Glycated Hb	Abbott Medical	LCP	Class II	1991-02-07
K901797	The Wonder Box	Micro Tronics Corp.	GWL	Class II	1991-02-07
K895859	Contain(tm)	Arbor Technologies, Inc.	GCX	Class II	1991-02-07
K905861	Aca(r) Lactic Dehydrogenase Isoenzyme 1 (Ld1) Meth	E.I. Dupont de Nemours & Co., Inc.	CFE	Class II	1991-02-06
K905462	Procedure Tray/for Various Ophthalmic Procedures	Angiosystems, Inc.	LRP	Class I	1991-02-06
K905460	Sterile Disposable Drape/ophthalmic Surgery	Angiosystems, Inc.	HMT	Class II	1991-02-06
K905365	Instrument Makar Gravity Assist System	Instrument Makar, Inc.	KYZ	Class I	1991-02-06
K905240	Vesseloops	Sparta Surgical Corp.	KDC	Class I	1991-02-06
K905143	Skin Marker	Aesculap Inc	FZZ	Class I	1991-02-06
K904244	Sensiderm	Ansell Intl.	KGO	Class I	1991-02-06
K902803	A Physiotherapy Apparatus	Grace River Ent., Inc.	ILY	Class II	1991-02-06
K910206	Philips Model S47 Bte Hearing Aid	Philips Hearing Instruments Co.	ESD	Class I	1991-02-05
K905720	Palmaz Biliary Stent	Johnson & Johnson Interventional Systems	DQY	Class II	1991-02-05
K905547	Softouch Guiding Catheter	Mallinckrodt Medical	DQY	Class II	1991-02-05
K905446	Meditronic Andover Medical Model 1690 Electrode	Medtronic Andover Medical, Inc.	DRX	Class II	1991-02-05
K905224	Cardiopulmonary Bypass Vascular Catheter	3M Health Care, Sarns	DWF	Class II	1991-02-05
K905041	Sunglasses	Eskco, Inc.	HQY	Class I	1991-02-05
K905027	Cup Out	Anspach Mfg., Inc.	HSZ	Class I	1991-02-05
K904992	Minnilert Air Detector	Medivators Inc	FJF	Class II	1991-02-05
K904611	Interpore Cylindrical Hex Implant	Interpore Intl.	DZE	Class II	1991-02-05
K904088	Artrac Vital Signs Mon. Models 7000 and 5000 & Acc	Sentinel	DQA	Class II	1991-02-05
K902690	Sonicaid Model Meridian 800	Oxford Medilog, Inc.	HGM	Class II	1991-02-05
K910198	Ciba Corning Acs Lh Immunoassay	Ciba Corning Diagnostics Corp.	CEP	Class I	1991-02-04
K910143	Kodak Extachem Clinical Chemistry Slides (Fe)	Eastman Kodak Company	JIY	Class I	1991-02-04
K910140	Electrapette (R)	Matrix Technologies Corp.	JQW	Class I	1991-02-04
K910087	Abuscreen Online Opiates Calibrators	Roche Diagnostic Systems, Inc.	DKB	Class II	1991-02-04
K905828	Abuscreen(r) Online Calibrators	Roche Diagnostic Systems, Inc.	DKB	Class II	1991-02-04
K905814	Lumatag(r) Fsh Chemiluminescence Immunometri Assay	London Diagnostics, Inc.	CGJ	Class I	1991-02-04
K905502	.010 Hi-Torque Floppy Guide Wire W/preshaped Tip	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1991-02-04