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 3408 of 3526

510(k) clearances, page 3408 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782008	Dressing, Environ Wound	Abbott Medical	KMF	Class I	1979-05-14
K790849	H-H Fixation and Joining Connectors	Holter-Hausner Intl.	JXG	Class II	1979-05-11
K790725	Barrier Surgical Drapes W/ Drisite* W/microcide*	Surgikos, Inc.	KKX	Class II	1979-05-11
K790678	Intrauterine Catheter Tip	Sonicaid, Inc.	KXO	Class II	1979-05-11
K790612	Nutriflow Nasogastric Feeding Tube	Biosearch Medical Products, Inc.	KNT	Class II	1979-05-11
K790607	Greenline Irrigation Trays	Snyder Laboratories, Inc.	EYN	Class II	1979-05-11
K790546	Flowmeter, Optiflo Gas	Cobe Laboratories, Inc.	DTX	Class II	1979-05-11
K790365	Fluid Measurement Stand	Hewlett-Packard Co.	FFG	Class II	1979-05-11
K790758	Hemoclear U-Nephros 1.0 Dialyzer	Medical, Inc.	FJG	Class II	1979-05-08
K790731	Oxygen Humidifier Kit	Abbott Medical	BTT	Class II	1979-05-08
K790642	Ley Electro-Surgical Units	Merced Medical, Inc.	GEI	Class II	1979-05-08
K790636	Kimlon Universal Drape	Kimberly-Clark Corporation	KKX	Class II	1979-05-08
K790562	Pulse Generator Model 61 and 128	Ela Medical, Inc.	DXY	Class III	1979-05-08
K790537	Automatic Electronic Sphymomonometer	Healthcare Enterprises, Inc.	DXN	Class II	1979-05-08
K790452	28 Unipolar and Bipolar Pulse Generators	Edwards Pacemaker Systems	DXY	Class III	1979-05-08
K790219	Prothesis, Retained Geometric Knee	Zimmer GmbH	JWH	Class II	1979-05-08
K790861	Moire Contourgraph, Models Ms-1, Ss-1	Otal Precision Co., Ltd.			1979-05-07
K790817	Ria Kit, Quantitation of Prostatic Acid	New England Nuclear	JFH	Class II	1979-05-07
K790783	Koordinat 3D	Siemens Corp.	KXJ	Class II	1979-05-07
K790677	Eo Evacuating System I	Castle Co.	FLI	Class II	1979-05-07
K790556	Cholesterol Reagent, Automated Enzymatic	Calbiochem-Behring Corp.	CHH	Class I	1979-05-07
K790550	Centria System	Union Carbide Corp.	JJG	Class I	1979-05-07
K790317	Pap Ria Kit	Yang Laboratories, Inc.	JFH	Class II	1979-05-07
K790120	Slendertone	Bloomex International, Inc.	IPF	Class II	1979-05-07
K790820	Non-Rebreathing T Piece	Dhd Medical Products Div. Diemolding Corp.	CBP	Class II	1979-05-04
K790809	Vs, Anesthesia Ventilator	Airco/Ohio Medical Products	CBK	Class II	1979-05-04
K790747	Mevatron 74	Siemens Medical Laboratories, Inc.	IYE	Class II	1979-05-04
K790673	Omnimedical Automatic 1001	Omnimedical	IZL	Class II	1979-05-04
K790604	Custom Tubing Sets	Norton Performance Plastics Corp.	FPA	Class II	1979-05-04
K790431	Treated Barrier Incise Drape	Surgikos, Inc.	KKX	Class II	1979-05-04
K790282	Eldoncard	Nordisk Infuser System	KSZ	Class II	1979-05-04
K790801	Sterile Defibrinated Sheep Blood	Central Biological Co.	JSK	Class I	1979-05-03
K790781	Spectrophotometer System, Model Aa-475	Varian Assoc., Inc.	JXR	Class I	1979-05-03
K790780	Atomic Absorption Spectrophotometer,	Varian Assoc., Inc.	JXR	Class I	1979-05-03
K790769	Beta/pak	Bio/Data Corp.	JOZ	Class II	1979-05-03
K790735	Emit-Tox Serum Calibrators	Syva Co.	DKB	Class II	1979-05-03
K790687	Brucella Broth W/sps, 6% Sorbitol & CO2	Gibco Laboratories Life Technologies, Inc.	JSC	Class I	1979-05-03
K790549	Heating Block, Wampole 37 C	Armkel, LLC	JRG	Class I	1979-05-03
K790543	The Abbott Executive	Abbott Medical	JQP	Class I	1979-05-03
K790514	I Netilmicin Ria Kit	Siemens Healthcare Diagnostics Inc.	JTB	Class I	1979-05-03
K790496	Biobrane Brand Temporary Wound Dressing	Woodroof Laboratories, Inc.	KGN	Unclassified	1979-05-03
K790495	Thyroxine Ria Kit	Technia Diagnostics, Ltd.	CDX	Class II	1979-05-03
K790485	Amylochrome Stat Separator, Test	Hoffmann-La Roche, Inc.	JKA	Class II	1979-05-03
K790483	Coulter Accu-Zyme II Got Reagent	Coulter Electronics, Inc.	CIT	Class II	1979-05-03
K790461	T-3 Uptake (Maa) Kit	Amersham Corp.	KHQ	Class II	1979-05-03
K790440	Progesterone	Serono Laboratories, Inc.	JLS	Class I	1979-05-03
K790372	H-D-El	General Diagnostics	LBR	Class I	1979-05-03
K790591	Hemodialysis Blood Circuit	Travenol Laboratories, S.A.	KOC	Class II	1979-05-02
K790533	Hd Capillary Film Dialyzer, Model 1001	Travenol Laboratories, S.A.	FJG	Class II	1979-05-02
K790382	Coil Dialysis, Models Dm-360 and Dm-360-	Estracorporeal, Inc.	FKD	Class II	1979-05-02