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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3407 of 3526

510(k) clearances, page 3407 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790924	Nebulizer No. M-175	Mem Medical, Inc.	CAF	Class II	1979-05-21
K790912	Aridyne 3500	Timeter Instrument Corp.	BTI	Class II	1979-05-21
K790600	Howmedica Strip Crown	Howmedica Corp.	DZN	Class I	1979-05-21
K790599	Ruwa Matrix Strips	Howmedica Corp.	DZN	Class I	1979-05-21
K790598	Ruwa Finishing Strips	Howmedica Corp.	EHM	Class I	1979-05-21
K790904	Stao-Hotpack	Staodynamics, Inc.	IMA	Class I	1979-05-18
K790770	Safety Holster, Single-Use	Aspen Laboratories, Inc.	GEI	Class II	1979-05-18
K790684	Color Coding of Surgical Instruments	Sara Dan, Inc.	FZT	Class I	1979-05-18
K790507	800 ECG Electrode	Simonsen & Weels Eftf.	DRX	Class II	1979-05-18
K790320	Delta-Lite	Johnson & Johnson Professionals, Inc.	ITG	Class I	1979-05-18
K790889	Circuit, Breathing (W Connec, Y Piece)	Airlife, Inc.			1979-05-17
K790886	Corrugated Flexible Polyethylene	Airlife, Inc.			1979-05-17
K790885	Nasal, Oxygen, Cannula	Airlife, Inc.	CAT	Class I	1979-05-17
K790884	Face Tent-Vinyl	Airlife, Inc.			1979-05-17
K790869	Cardio-Slidecomp	Creative Instruments	DPS	Class II	1979-05-17
K790846	Middle Ear Analyzer (Imped. Audiomtr)	Grason-Stadler, Inc.	EWO	Class II	1979-05-17
K790633	Accor Matrix	Accor, Inc.	DZN	Class I	1979-05-17
K790503	Cardiotest 2200	Cardiac Pacemakers, Inc.	DTA	Class II	1979-05-17
K790837	Arrhythmia II Cardule	Spacelabs, Inc.	DSI	Class II	1979-05-16
K790779	Model H39c-Behing-the-Ear Hearing Instru	Marcon Hearing Instruments, Inc.			1979-05-16
K790749	Colostomy Enema Device	Vabar Corp.	EXD	Class II	1979-05-16
K790737	Hsi Model C. Custom in-the-Ear Hear/aid	Hearing Services, Inc.	ESD	Class I	1979-05-16
K790690	Omni-Stanicor-(Theta) Model 217	Cordis US Corp.	DXY	Class III	1979-05-16
K790586	Chembond	L.D. Caulk Co.	EMA	Class II	1979-05-16
K790585	Finesse	L.D. Caulk Co.	EBF	Class II	1979-05-16
K790407	Microtec Bacterial Filter	Medex, Inc.	DRS	Class II	1979-05-16
K790249	Test Cells	Hyland Therapeutic Div., Travenol Laboratories	KSF	Class II	1979-05-16
K790859	Permobil Superior	Saab-Scania of America, Inc.	ITI	Class II	1979-05-15
K790858	Permobil Exterior	Saab-Scania of America, Inc.	ITI	Class II	1979-05-15
K790830	Emit Gentamicin Control	Syva Co.	LAS	Class I	1979-05-15
K790829	Emit Gentamicin Assay	Syva Co.	DJB	Class II	1979-05-15
K790815	Culturette Brand Pva	Marion Laboratories, Inc.	IGM	Class I	1979-05-15
K790771	Ld-P Reagent (Ldh P-L Reagent)	Gilford Diagnostics	CFJ	Class II	1979-05-15
K790665	Neonatal Ty Autopak Test Delivery System	Micromedic Systems	CDX	Class II	1979-05-15
K790662	Centrifichem Inorganic Phosphorus	Union Carbide Corp.	CED	Class I	1979-05-15
K790588	Assay Reagents, Lsa 290	Kallestad Laboratories, Inc.	JEW	Class I	1979-05-15
K790581	Chromatography Tubes	Miles Laboratories, Inc.	CDP	Class II	1979-05-15
K790578	Gamma Smac Reagents	Gamma Enterprises, Inc.	CIG	Class II	1979-05-15
K790421	Roche Lactate Analyzer 640	Roche Medical Electronics, Inc.	KHP	Class I	1979-05-15
K790315	Blood Cell Separator System Cs3000	Travenol Laboratories, S.A.	FRN	Class II	1979-05-15
K790871	Enclosed Case Cart	Hamilton Industries, Inc.			1979-05-14
K790762	Platform Tcck Total Knee	Zimmer GmbH	HRY	Class II	1979-05-14
K790750	Colostomy Device W/ Pressure Lid	Vabar Corp.	EXD	Class II	1979-05-14
K790746	The Bionic Exerciser	Scudder Molner Instruments	HCC	Class II	1979-05-14
K790674	The Surgical Assistant	Instrument Makar, Inc.	FWZ	Class I	1979-05-14
K790669	Drop Controller	Imed Corp.	FLN	Class II	1979-05-14
K790519	Ultralite Urosystem, Models Gu-1 & Gu-2	American Medical Systems, Inc.	FAP	Class II	1979-05-14
K790436	Implantable Heart Lead Terminal Adapter	Arco Medical Products Co.	DTD	Class II	1979-05-14
K790322	Optional Accessory Foot Switch Model 100	Applied Medical Research	EBW	Class I	1979-05-14
K790104	Pistormatic	Zelby, Burstein, Hartman & Burstein	KZH	Class II	1979-05-14