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 3386 of 3526

510(k) clearances, page 3386 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791811	Spectrum Automatic Chest Unit Model C	Spectrum X-Ray Corp.	KPX	Class II	1979-10-26
K791809	Blood Transfusion Microfilter	Pioneer Viggo, Inc.	FPB	Class II	1979-10-26
K791790	Model Tm5 Behind Ear Tinnitus Masker	Starkey Laboratories, Inc.	KLW	Class II	1979-10-26
K791775	Varian V-3300, Phased Array Ultrason	Varian Assoc., Inc.	IYO	Class II	1979-10-26
K791774	Life Care 1000Ml.emp. Cont. W/at. Y-Tran	Abbott Medical	KPE	Class II	1979-10-26
K791761	Circuit, Breathing W/wo Nebulizer	Airlife, Inc.	BZO	Class I	1979-10-26
K791758	Clinifeeding System 1	Roussel (Canada), Ltd.	KNT	Class II	1979-10-26
K791755	Datason-Gs	General Electric Co.	IYO	Class II	1979-10-26
K791744	Varian V-3400, Phased Array Ultrason	Varian Assoc., Inc.	IYO	Class II	1979-10-26
K791704	Masterscale II	Litton Dental Products	ELC	Class II	1979-10-26
K791672	Albumin Intravenous Administration Set	Delmed, Inc.	FPA	Class II	1979-10-26
K791576	Forget - Denture Bonding Liquid	Norcliff Thayer, Inc.	KOL	Class I	1979-10-26
K791535	Hollister Stoma Pouch with Micro Adhes	Hollister, Inc.	EXB	Class I	1979-10-26
K791526	Hollister Stoma Pouch Skin Barrier	Hollister, Inc.	EXB	Class I	1979-10-26
K791525	Hollister Karaya Paste	Hollister, Inc.	EXB	Class I	1979-10-26
K791522	Flow Medical X-Ray Protective Gloves	Flow X-Ray Corp.	KPY	Class I	1979-10-26
K791490	Unipuncture Catheter	Hospal Medical Corp.	FIE	Class II	1979-10-26
K791489	Vital Catheter	Hospal Medical Corp.	FIE	Class II	1979-10-26
K791373	Roche Immunochemical Ld Isoenzy Reagents	Hoffmann-La Roche, Inc.	CFE	Class II	1979-10-26
K791733	Light-Pak	Midwest	EAY	Class I	1979-10-23
K791721	Ultravue Blended Bifocal Lens	American Optical Corp.	HQG	Class I	1979-10-23
K791716	Plaque-X Denture Cleanser	Noxell	JER	Class I	1979-10-23
K791673	Empty Transfer Bag	Delmed, Inc.	KSR	Class II	1979-10-23
K792052	Implantable Programmable Unipolar Card	Telectronics, Inc.	DXY	Class III	1979-10-22
K791885	i.v. Start Set	Ascep, Inc.	KGX	Class I	1979-10-22
K791788	Micro-Ring System Precision Attach.	Howmedica Corp.	EGG	Class I	1979-10-22
K791783	Omni-Stanicor (Theta) Mod 237A	Cordis US Corp.	DXY	Class III	1979-10-22
K791773	Ventilator Tube with Filter	Pharmaseal Div., Baxter Healthcare Corp.	CAH	Class II	1979-10-22
K791699	Hydradjust II Urological Table	Sybron Corp.	KQS	Class I	1979-10-22
K791681	The Denver Splint	Xomed, Inc.	EPP	Class I	1979-10-22
K791541	Ems Adapter Model 9160	Concept, Inc.	GEI	Class II	1979-10-22
K791088	Monoject Pulp-Capping Material	Sherwood Medical Co.	EJK	Class II	1979-10-22
K790984	Klip-Lite	Innovators, Inc.	EAZ	Class I	1979-10-22
K790823	Visio-Dispers	Espe GmbH (US)	EBF	Class II	1979-10-22
K791994	Creatinine Diag. Reagent Picric Acid	Connecticut Diagnostics, Ltd.	CGX	Class II	1979-10-17
K791990	Technicon Hdl Cholesterol Method	Technicon Instruments Corp.	LBS	Class I	1979-10-17
K791989	Technicon C202 System	Technicon Instruments Corp.	CGA	Class II	1979-10-17
K791984	Scissor's #'S 2294,2262,2263	Edward Weck, Inc.	FZT	Class I	1979-10-17
K791968	Eia (Elisa) Reader	Gilford Instrument Laboratories, Inc.	JJQ	Class I	1979-10-17
K791966	Aerobitron 1	Stanford Scientific, Inc.	ISD	Class II	1979-10-17
K791958	Seracon - El Do27	Bhp Diagnostix, Inc.	JJY	Class I	1979-10-17
K791952	Dexide Disposable Surgical Scrub Brush	Dexide, Inc.	GEC	Class I	1979-10-17
K791951	Dexide Disposable Surgical Scrub Sponge	Dexide, Inc.	GEC	Class I	1979-10-17
K791950	Dexide Disposable Surgical Scrub Sponge	Dexide, Inc.	GEC	Class I	1979-10-17
K791949	Dexide Disposable Surgical Scrub Brush	Dexide, Inc.	GEC	Class I	1979-10-17
K791926	Hand Towel	Procter & Gamble Mfg. Co.	NAB	Class I	1979-10-17
K791924	Pdc 104 Single Swab Culture Collection	Precision Dynamics Corporation	JTW	Class I	1979-10-17
K791902	Linde Oxygen Walker Sys. Mark II-L	Union Carbide Corp.	BYJ	Class II	1979-10-17
K791896	Centria Phenytoin Ria Test Set	Ventrex Laboratories, Inc.	DLP	Class II	1979-10-17
K791889	Suture Removal Tray, Reorder 7950&7951	Ascep, Inc.	FSM	Class I	1979-10-17