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 3472 of 3526

510(k) clearances, page 3472 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771853	Permagum Adhesive	Espe GmbH (US)	ELW	Class II	1977-10-13
K771846	Suogipeel Packaging System	Surgicot, Inc.	FRG	Class II	1977-10-13
K771827	Intravenous Filter W/flash Bulb	Jelco Laboratories	FPB	Class II	1977-10-13
K771826	Intravenous Filter W/auto Air Vent	Jelco Laboratories	FPB	Class II	1977-10-13
K771758	Elastomull Gauze Bandage	Beiersdorf, Inc.	FQM	Class I	1977-10-13
K771757	Exam Gloves	Jamar Health Products, Inc.	FMC	Class I	1977-10-13
K771712	Catheter Dressing Chance Set	Shield Laboratories, Inc.	FRL	Class I	1977-10-13
K771667	Blood Gas Tray #4024	Concord Laboratories, Inc.	FMI	Class II	1977-10-13
K771657	Emit Thyroxine Control	Syva Co.	JJX	Class I	1977-10-13
K771381	IV Catheter Hub	Jelco Laboratories	FOZ	Class II	1977-10-13
K771158	Id Braclets, Adult & Infant	Divers-A-Med	LDR	Class II	1977-10-13
K771224	Radovan Subcutaneous Tissue Expander	Heyer Schulte Corp.	LCJ	Unclassified	1977-10-11
K771855	Omnicor Programmer Model 222A	Cordis US Corp.	KRG	Class III	1977-10-07
K771815	Sigmoscope	Dynatech Cryomedical Co.	FAM	Class II	1977-10-07
K771790	Detectoterge Azide Free	J.T. Baker Chemical Co.	GKL	Class II	1977-10-07
K771789	Blanking Solution Hgb	J.T. Baker Chemical Co.	GKR	Class II	1977-10-07
K771788	Cymet-Automated	J.T. Baker Chemical Co.	GGK	Class I	1977-10-07
K771787	Azide Free Blood Diluting Reagent	J.T. Baker Chemical Co.	GIF	Class I	1977-10-07
K771771	Quan. Color. Deter. of Serum Albumin	Stanbio Laboratory	DCF	Class II	1977-10-07
K771768	Goat Lambda-Light Chain Anti-Human Serum	G.D. Searle and Co.	DEH	Class II	1977-10-07
K771766	T3u	Union Carbide Corp.			1977-10-07
K771649	Hemoglobin A2 Testing System	Isolab, Inc.	JBD	Class II	1977-10-07
K771638	Igoxin Solid Phase Ria	BD Becton Dickinson Vacutainer Systems Preanalytic	DPO	Class II	1977-10-07
K771610	Carbon Dioxide Analyzer	Corning Medical & Scientific	CIE	Class II	1977-10-07
K771539	Stepper	Tridak	KYX	Class I	1977-10-07
K771256	Gas Chromatograph	Varian Assoc., Inc.			1977-10-07
K771245	Model 2/2 Analyzer	Eastman Kodak Company	JJE	Class I	1977-10-07
K771825	Carba Linguarduc	C.R. Bard Inc	ILQ	Class II	1977-10-06
K771710	Worrell Patella Template	Depuy, Inc.	HWT	Class I	1977-10-06
K771709	Worrell Trial Patella	Depuy, Inc.	HWT	Class I	1977-10-06
K771708	Worrell Patella	Depuy, Inc.	HTG	Class II	1977-10-06
K771779	Catheterization Sys. Urinary Drainage	Medical Devices Inc.	KOD	Class II	1977-10-05
K771714	Slide Stainers Gls 360 & 360-1	Honeywell, Inc.	KEY	Class I	1977-10-05
K770835	Patch Fabric	Usci, Div. C.R. Bard, Inc.	DXZ	Class II	1977-10-05
K771859	Needle Holder, Microvascular	Edward Weck, Inc.	FHQ	Class I	1977-10-04
K771806	Thorek Scissors 7 1/4 & 10	J. Sklar Mfg. Co., Inc.	FZT	Class I	1977-10-04
K771805	Aca Salicylate Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1977-10-04
K771799	Aca Alcohol Calibrators	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1977-10-04
K771791	Needle Counting	Chase Mfg. Co.	MMK	Class II	1977-10-04
K771782	Dinimap Model 827A	Applied Medical Research	DXN	Class II	1977-10-04
K771780	Las-R Tm	Hyland Therapeutic Div., Travenol Laboratories	DEB	Class II	1977-10-04
K771772	Dinamap Model 825A	Applied Medical Research	DSK	Class II	1977-10-04
K771763	Hemo-Ro	EMD Millipore Corporation	FIP	Class II	1977-10-04
K771762	Modular Hearing Device, Model S291	Vicon Instrument Co.	ESD	Class I	1977-10-04
K771761	Solid Oxygen System	Jet Research Center, Inc.	CAW	Class II	1977-10-04
K771705	Rs-7800 Minipump	Renal Systems, Inc.	FIR	Class II	1977-10-04
K771703	Enteric 20	Inolex Corp./Div of Biomedical	JSS	Class I	1977-10-04
K771692	Tubing Sets	Cobe Laboratories, Inc.	DWF	Class II	1977-10-04
K771551	i.v. Prep & Care Kit	Jelco Laboratories	FRL	Class I	1977-10-04
K771540	Magnatherm 2000	Intl. Medical Electronics, Ltd.	IMJ	Class II	1977-10-04