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 2026-11-05, 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 2300 of 3531

510(k) clearances, page 2300 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925899	Ambulatory Blood Pressure Monitor, Mdl# 5100-01	Welch Allyn Inc	DSK	Class II	1993-05-21
K925851	Cook Tissue Morcellator	Cook Incorporated	GEI	Class II	1993-05-21
K925462	Breathing Filters 1942T/1941t/2014t	Intersurgical Ltd.	CAH	Class II	1993-05-21
K925442	Sarns Retrograde Cannula	3M Health Care, Sarns	DWF	Class II	1993-05-21
K925395	Technomed Pulsolith 4000 Laser System	Teknomed, Inc.	LNK	Class II	1993-05-21
K925024	Orc Tappered Irrigating Probe	O.R. Concepts, Inc.	GCY	Class I	1993-05-21
K924968	L-Cath Peel-Away Catheter System	Luther Medical Products, Inc.	FOZ	Class II	1993-05-21
K924917	Harmonic Scalpel 5Mm Laparosonic Blade Accessory	Ultracision, Inc.	GEI	Class II	1993-05-21
K924605	Magnetic Resonance Diagnostic Accessory	General Electric Co.	LNH	Class II	1993-05-21
K924396	Clotting Factor-VIII-IX-XI-XII Deficient Plasma	Behring Diagnostics, Inc.	GJT	Class II	1993-05-21
K924279	Playtex Flushable Tampons, Regular, Super, Super +	Playtex Family Products, Inc.	HIL	Class II	1993-05-21
K923439	Luneau Umbilical Cord Clamp	Laboratoires Luneau	HFW	Class II	1993-05-21
K921115	Ultra Thin Menstrual Pad	Icd Products	HHD	Class I	1993-05-21
K921015	Sharpe Endosponge Aspiirator	Paladin Medical, Inc.	HET	Class II	1993-05-21
K920049	Medix Pc-305 Neonatal Incubator	Medix I.C.S.A.	FMZ	Class II	1993-05-21
K931290	Remel Cefmetazole 30 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1993-05-20
K931224	Vidas Total Ige (Ige) Assay	Biomerieux Vitek, Inc.	DGP	Class II	1993-05-20
K931169	Mdt Dental Chair	Mdt Corp., Inc.	KLC	Class I	1993-05-20
K931110	Radias Free T4 Enzyme Immunoassay	Bio-Rad	CEC	Class II	1993-05-20
K931060	Statview	Image Data Corp.	LMD	Class I	1993-05-20
K930959	Factor Control [P]	American Bioproducts Co.	GGC	Class II	1993-05-20
K926443	Cobas(r)-Fp Reagents for T-Uptake/calibrators	Roche Diagnostic Systems, Inc.	KHQ	Class II	1993-05-20
K926114	Hep-2 Antinuclear Antibody Test System	Tissue Culture Biotec, Inc.	DHN	Class II	1993-05-20
K925945	Maverick Percutaneous Transluminal Angioplasty Cat	Scimed Life Systems, Inc.	LIT	Class II	1993-05-20
K925220	Pmi100 Video Imager	Kulzer GmbH	LMC	Class II	1993-05-20
K924358	Accemt Dg(tm) Balloon Angioplasty Cath, Modified	Cook Inc.	LIT	Class II	1993-05-20
K923703	Kaneda Anterior Spinal Multisegmental Fixation Dev	Acromed Corp.	KWQ	Class II	1993-05-20
K923246	Sonace 2000	Medison Co., Ltd.	IYO	Class II	1993-05-20
K921706	Meadox(r) Surgimed Olbert Catheter System(r)	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1993-05-20
K915743	Sharpe Endotenaculum	Paladin Medical, Inc.	HET	Class II	1993-05-20
K914378	Peripheral Intervenous Catheter	Medical Profiles, Inc.	FOZ	Class II	1993-05-20
K910599	Cardiopulmonary Bypass Level Sensing Monitor	Jtl Medical Corp.	DTW	Class II	1993-05-20
K931842	Breathing Filter	Mag, Inc.	CAH	Class II	1993-05-19
K931800	Mag Connectors and Airway Extensions	Mag, Inc.	BZA	Class I	1993-05-19
K931591	Itc Model Adobe 100 Canal	Widex Hearing Aid Co., Inc.	ESD	Class I	1993-05-19
K931590	Ite Model Adobe 100 Full Custom	Widex Hearing Aid Co., Inc.	ESD	Class I	1993-05-19
K931049	Advantx System	GE Healthcare	IZO	Class I	1993-05-19
K930792	Rsx 30Hf	Fischer Imaging Corp.	IZO	Class I	1993-05-19
K930015	Sternal Band	Stony Brook Surgical Innovations, Inc.	JDQ	Class II	1993-05-19
K926416	Sat Pad(tm)	Alliance Pharmaceutical Corp.	LNH	Class II	1993-05-19
K926126	Suturemate	Surgical Safety Products, Inc.	MDM	Class I	1993-05-19
K925987	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1993-05-19
K925870	Spacer	Bip USA, Inc.	MJG	Class I	1993-05-19
K925145	Trace Model #'S 840, 841, 842, 845	Trace Medical Equipment, Inc.	FYH	Class I	1993-05-19
K925029	Mrinnervu Endorectal Prostate Coil	Medrad, Inc.	LNH	Class II	1993-05-19
K924952	Elisa-Doxa Combi-6	Advanced Biological Products, Inc.	LLL	Class II	1993-05-19
K924951	Elisa-Doxa Combi-4	Advanced Biological Products, Inc.	LLL	Class II	1993-05-19
K924950	Elisa-Doxa Jo-1	Advanced Biological Products, Inc.	LLL	Class II	1993-05-19
K924949	Elisa-Doxa Scl-70	Advanced Biological Products, Inc.	LLL	Class II	1993-05-19
K924948	Elisa-Doxa Sm/rnp	Advanced Biological Products, Inc.	LLL	Class II	1993-05-19