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 2943 of 3529

510(k) clearances, page 2943 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854599	Vickers Medical Model 273 Oxygen Monitor	Vickers, Ltd.	CCL	Class II	1985-11-27
K854474	External Ventricular Drainage/monitoring/lumbar Se	Cordis US Corp.	JXG	Class II	1985-11-27
K854049	Heyer-Schulte Syringo Peritoneal Shunt	American V. Mueller	JXG	Class II	1985-11-27
K851190	Nystagmograph Eog/eng Analyses	Nicolet Biomedical Instruments	GWN	Class II	1985-11-27
K850683	72 Determ. Size Radial Immunodiffusion Test Alpha2	Kent Laboratories, Inc.	DEB	Class II	1985-11-27
K854540	Raichem/k.e	Reagents Applications, Inc.	JJQ	Class I	1985-11-26
K854448	Autoscan W/a System	American Micro Scan	JTO	Class I	1985-11-26
K854353	Platelet-Trol II	R & D Systems, Inc.	JPK	Class II	1985-11-26
K854345	Technicon Ra-500 System	Technicon Instruments Corp.	JJC	Class I	1985-11-26
K854297	Medsurg Percutaneous Transhepatic Cholangiogram	Medsurg Industries, Inc.	KNW	Class II	1985-11-26
K854292	Medsurg Arthrogram Tray	Medsurg Industries, Inc.	LRO	Class II	1985-11-26
K854291	Med Surg Percutaneous Aspiration Biopsy(pab)tray	Medsurg Industries, Inc.	KNW	Class II	1985-11-26
K854289	Medsurg Ultrasound Biopsy Tray	Medsurg Industries, Inc.	FCG	Class II	1985-11-26
K854088	Unitek Lift-Off Debracketing Instrument	Unitex Corp.	JEX	Class I	1985-11-26
K854050	Excel Bracket Adhesive	Johnson & Johnson Professionals, Inc.	DYH	Class II	1985-11-26
K854024	Corning Magic Mab Hcg Radioimmunoassay	Corning Medical & Scientific	JHI	Class II	1985-11-26
K854019	Port-Gard	Cormed, Inc., Sub. C.R.Bard, Inc.	LJT	Class II	1985-11-26
K853755	Acoustically-Coupled Electronic Phantom 84-410	Victoreen, Inc.	ITX	Class II	1985-11-26
K853750	Sys*stim 207 Model Me 207	Mettler Electronics Corp	IPF	Class II	1985-11-26
K853554	Pathfinder Direct Antigen Detection Sys Rotavirus	Kallestad Laboratories, Inc.	LIQ	Class I	1985-11-26
K852704	Tweetheart #102 Fetal/neonatal Heartbeat Annunciat	Clincal Instruments Corp.	HGM	Class II	1985-11-26
K851149	Key Med Transendoscopic Vascular Detector Tvd-1	Keymed, Inc.	JAF	Class II	1985-11-26
K842830	Immunoper-Oxidase Test Kit for Detect of	Bartels Immunodiagnostic Supplies, Inc.	GQN	Class II	1985-11-26
K854553	Total Protein	American Monitor Corp.	CEK	Class II	1985-11-25
K854515	Shaw Sun Systems 1000, 2000 & 3200	Shaw Sun Systems	FTC	Class II	1985-11-25
K854503	Ast(optimized) Reagent	Sigma Diagnostics, Inc.	CIT	Class II	1985-11-25
K854502	Alt(optimized) Reagent	Sigma Diagnostics, Inc.	CKA	Class I	1985-11-25
K854498	Spectra 724	Daavlin Co.	FTC	Class II	1985-11-25
K854421	Tdx R Opiates	Abbott Medical	DJG	Class II	1985-11-25
K854419	Tdx Cortisol	Abbott Medical	JFT	Class II	1985-11-25
K854366	Enzymatic Triglycerides Gpo-Grinder Method	American Monitor Corp.	CDT	Class I	1985-11-25
K854221	Diesse Crp Test Kit	Marvic Interpharma, Inc.	DCK	Class II	1985-11-25
K854190	Cantrol Spinal Fluid Control	Canyon Diagnostics, Inc.	DFI	Class I	1985-11-25
K854188	In Vitro Test Determination of Inorganic Phosphoro	Clinical Data, Inc.	CEO	Class I	1985-11-25
K854187	In-Vitro Test Determination of Sgot (Ast)	Clinical Data, Inc.	CIS	Class II	1985-11-25
K854185	In-Vitro Test Determination of Uric Acid	Clinical Data, Inc.	KNK	Class I	1985-11-25
K854182	In-Vitro Test Determination of Trialyceride	Clinical Data, Inc.	CDT	Class I	1985-11-25
K854181	In-Vitro Test Determination of Albumin	Clinical Data, Inc.	CIX	Class II	1985-11-25
K854180	In-Vitro Test Determination Total Bilirubin	Clinical Data, Inc.	CIG	Class II	1985-11-25
K854179	In-Vitro Test for the Determination of Cholesterol	Clinical Data, Inc.	CHH	Class I	1985-11-25
K854178	In-Vitro Test for the Determination of Creatinine	Clinical Data, Inc.	CGX	Class II	1985-11-25
K854177	In-Vitro Test for the Determination of Glucose	Clinical Data, Inc.	CGA	Class II	1985-11-25
K854095	Biopsy Tray I & II	North Coast Medi-Tek	LRO	Class II	1985-11-25
K854006	Plastelast And/or Elastoplaste	Cp Medical	KGX	Class I	1985-11-25
K853917	Egnell Compact Suction Pump	Egnell, Inc.	BTA	Class II	1985-11-25
K853909	Egnell Universal Suction Pump	Egnell, Inc.	BTA	Class II	1985-11-25
K853886	P.c.a. Universal Acetabular Component System	Howmedica Corp.	JDI	Class II	1985-11-25
K853020	Porocoat Synatomic Unicondylar Knee	Depuy, Inc.	HSX	Class II	1985-11-25
K851885	Omiderm Wound & Burn Dressing	Biosystems Assoc.	FRO	Unclassified	1985-11-25
K850682	72 Determ. Size Radial Immuno. Test Human Cerulopl	Kent Laboratories, Inc.	DDB	Class II	1985-11-25