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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1726 of 3533

510(k) clearances, page 1726 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991266	<Genx> Embryo Transfer Catheter Cc Glider	<Genx> Intl., Inc.	MQF	Class II	1999-09-09
K991264	<Genx> Single Lumen Sideport Needle	<Genx> Intl., Inc.	MQE	Class II	1999-09-09
K991262	<Gen>single Lumen Needle	<Genx> Intl., Inc.	MQE	Class II	1999-09-09
K991022	<Genx> Sperm Washing Media	<Genx> Intl., Inc.	MQL	Class II	1999-09-09
K991020	<Genx> Double Lumen Needle	<Genx> Intl., Inc.	MQE	Class II	1999-09-09
K990335	Philips Easyvision Workstation:	Philips North America LLC	LNH	Class II	1999-09-09
K992897	Impregum Penta	Espe Dental AG	ELW	Class II	1999-09-08
K992895	Impregum F	Espe Dental AG	ELW	Class II	1999-09-08
K992893	Dentapure Dp 90 Cartridge, Dentapure Dp 365 Cartridge	Mrlb Intl., Inc.	EIA	Class I	1999-09-08
K992765	Cynosure Dioderm	Cynosure, LLC	GEX	Class II	1999-09-08
K992640	Slimline Surgical Clamp; Slimline Jaw Inserts	Minumys Surgical, Inc.	DXC	Class II	1999-09-08
K992472	Sureguide CO2 Laser Beam Delivery System	Clinicon Corp.	GEX	Class II	1999-09-08
K992379	Radionics Xdc External Ventricular Catheter	Radionics, Inc.	JXG	Class II	1999-09-08
K992305	Medi-Stim Butterfly Flowmeter, Model Bf1000-Bf2004	Medi-Stim, Inc.	ITX	Class II	1999-09-08
K992259	Echocardiography System Series 95000	Camtronics, Ltd.	LLZ	Class II	1999-09-08
K992135	Signa Profile/i Magnetic Resonance System	GE Healthcare	LNH	Class II	1999-09-08
K992090	Millennium Gold	Skytron, LLC	FSY	Class II	1999-09-08
K992044	Infusion Dynamics Power Infuser Model M100b	Infusion Dynamics, Inc.	FRN	Class II	1999-09-08
K992013	Del2940 Dental Erbium Laser, Delite Dental Erbium Laser	Continuum Biomedical, Inc.	GEX	Class II	1999-09-08
K991996	Impact-Plus, Impact-20, Dp97, Dp97-20, Dp-Pour and Dp-Repair	Denplus, Inc.	EBI	Class II	1999-09-08
K991754	Go Glucose Monitoring System	Lxn Corp.	CGA	Class II	1999-09-08
K991683	PTFE Ringed Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DYF	Class II	1999-09-08
K992868	Dentapure Dp40 Cartridge	Mrlb Intl., Inc.	EIA	Class I	1999-09-07
K992610	Gendex 765Dc, Model 110-0154	Dentsply Intl.	EHD	Class II	1999-09-07
K992225	Quantitative Flow	Philips North America LLC	LNH	Class II	1999-09-07
K992170	N-Dex Blue Powder-Free Nitrile Medical Examination Glove	Best Manufacturing Company	LZA	Class I	1999-09-07
K991901	Bio-97	Jeneric/Pentron, Inc.	EJT	Class II	1999-09-07
K992896	Dxss Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)	Dental X-Ray Support Systems, Inc.	EGY	Class II	1999-09-03
K992753	Cadplan Plus: 3D Treatment Planning System	Varian Assoc., Inc.	MUJ	Class II	1999-09-03
K992677	Eagle Option for the Qdr Bone Densitometer, Models Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w	Hologic, Inc.	KGI	Class II	1999-09-03
K992659	O2n Demand-II, Victor Model Ocpr-II	Thermadyne Holings Corp.	NFB	Class II	1999-09-03
K992578	Urine Chemistry Control, Level 2	Consolidated Technologies, Inc.	JJW	Class I	1999-09-03
K992576	Urine Chemistry Control, Level 1	Consolidated Technologies, Inc.	JJW	Class I	1999-09-03
K992401	Bact/alert Pf	bioMerieux, Inc.	MDB	Class I	1999-09-03
K992400	Bactalert Fa	bioMerieux, Inc.	MDB	Class I	1999-09-03
K992297	Pasco Mic and Mic/id Panels, Levofloxacin	Pasco Laboratories, Inc.	JTN	Class II	1999-09-03
K992280	Lorad 1-650 (International 650)	Lorad Corp.	IZH	Class II	1999-09-03
K992246	Qct Bone Mineral Analysis Software	Image Analysis, Inc.	KGI	Class II	1999-09-03
K992193	Endo-Esophageal Mr Coil	Surgi-Vision, Inc.	MOS	Class II	1999-09-03
K992166	The Aptus (Automated) Application of the Hsv 1/2 Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for	Zeus Scientific LLC	LGC	Class II	1999-09-03
K992137	Urological Catheter	Apogee, Inc.	GBM	Class II	1999-09-03
K992130	Pacific Hemostasis Thromboscreen 400C	Pacific Hemostasis	KQG	Class II	1999-09-03
K992108	Pasco Mic and Mic/id Panels (Cefepime)	Pasco Laboratories, Inc.	JWY	Class II	1999-09-03
K992088	Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture	Genzyme Surgical Product (Genzyme Biosurgery)	GAM	Class II	1999-09-03
K992077	Pasco Mic and Mic/id Panels (Ofloxacin)	Pasco Laboratories, Inc.	JTN	Class II	1999-09-03
K992063	Osteo Ic Femoral and Tibial Nails in Titanium Alloy	Howmedica Osteonics Corp	HSB	Class II	1999-09-03
K992023	Grand Ceram	Noritake Co., Inc.	EIH	Class II	1999-09-03
K992005	Giltech Plus Transparent Dressing	Giltech Plus, Inc.	MGP	Unclassified	1999-09-03
K991979	Sof-Set Micro Qr Infusion Set, Models 320 and 321	Medtronic, Inc.	FPA	Class II	1999-09-03
K991973	Capiox Sx10 Hardshell Resevoir	Terumo Medical Corp.	DTN	Class II	1999-09-03