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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3239 of 3528

510(k) clearances, page 3239 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820574	Armboard for Intravenous Anes. in Dental	David Simmonds Co., Inc.	BWN	Class I	1982-03-23
K820566	Patient Isolator #S-10/D-10	Microelectrodes, Inc.	FFT	Class I	1982-03-23
K820475	Mgc/litton 2300	Medical Graphics Corp.	BZL	Class II	1982-03-23
K820464	Hollister Odor Absorbing Wound Pad	Hollister, Inc.	NAB	Class I	1982-03-23
K820420	Am. Ph. Sterile Feeding Tube	American Pharmaseal Div. Ahsc	KNT	Class II	1982-03-23
K820419	Am. Ph. Sterile Single-Use Urethral Cath	American Pharmaseal Div. Ahsc	KOD	Class II	1982-03-23
K820294	Boston Syringe	Frisco Products, Inc.	FMF	Class II	1982-03-23
K820269	Rng Series Ultrasound Needle/cath. Gds	CIVCO Medical Instruments Co., Inc.	DWO	Class I	1982-03-23
K820221	Hydrogen Peroxide Topical; Formaldehyde	Renal Systems, Inc.	LIF	Class II	1982-03-23
K820215	Improved Dycal	Dentsply Intl.	EJK	Class II	1982-03-23
K820173	Cobe Single-Needle Controller #18-756	Cobe Laboratories, Inc.	FIF	Class II	1982-03-23
K820144	Disa Water Cystometer	Disa Electronics	FAP	Class II	1982-03-23
K820128	Uni-Set	Inhalation Therapy Equipment, Co.	BZO	Class I	1982-03-23
K820125	Cobe Centry 2000 Rx	Cobe Laboratories, Inc.			1982-03-23
K813581	Cruciate Ligament Button	Zimmer GmbH	KGS	Class I	1982-03-23
K813574	Sorb II	bioMerieux, Inc.	FKT	Class II	1982-03-23
K813107	Compudial/kp-1	Computer Dialysis Systems, Inc.	LIF	Class II	1982-03-23
K820399	Hs20 Port. Operating Room Monitor	Medtel Pty., Ltd.	DRT	Class II	1982-03-22
K813563	Phadezym Analyzer	Pharmacia, Inc.	JJQ	Class I	1982-03-22
K820664	Disposable Electrode	Trident Surgical Corp.	HAM	Class II	1982-03-19
K820660	A Hook Driver	Twin City Surgical, Inc.	KWP	Class II	1982-03-19
K820659	A Caliper	Twin City Surgical, Inc.	KTZ	Class I	1982-03-19
K820621	Nasal Instruments	Applied Fiberoptics, Inc.	EQH	Class I	1982-03-19
K820598	Hot & Cold Pulp Tester #4001	Analytic Technology	EAT	Class II	1982-03-19
K820593	Esp Series (X-Ray Generators	Xonics Medical Systems, Inc.	IZO	Class I	1982-03-19
K820562	Campylobacter Selective Medium	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-19
K820561	Sabouraud Dextrose Agar	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-19
K820560	Phenylethanol Agar W/5% Sheep Blood	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-19
K820559	Anaerobe Blood Agar	American Laboratory Supply, Inc.	JSG	Class I	1982-03-19
K820557	Dermathphyte Test Medium	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-19
K820551	Brucella Agar W/15% Sheep Blood	American Laboratory Supply, Inc.	JSG	Class I	1982-03-19
K820550	Potato Dextrose Agar	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-19
K820530	T-IV Elite Alloy	Howmedica Corp.	EJS	Class II	1982-03-19
K820510	Tympanostomy Tubes (Various Models	Abco Dist.	ETD	Class II	1982-03-19
K820503	Svensk Tk/2	Peter Martin Associates, Inc.	JEQ	Class I	1982-03-19
K820489	Ultrafine Tray Adhesive	Buffalo Dental Mfg Co Inc	ELW	Class II	1982-03-19
K820488	Champion - Hearing Aid	Electrone, Inc.	ESD	Class I	1982-03-19
K820456	Crown & Bridge Resin for Fabricat/de	Rohm and Haas Co.	EBG	Class II	1982-03-19
K820284	Root Canal Filling Resin	Dentsply Intl.	KIF	Class II	1982-03-19
K820016	Uvex Alpha, Beta, Gamma & Delta Sun	Bacou USA, Inc. and Uvex Safety, Inc.	HQY	Class I	1982-03-19
K813601	E.w.l. P-TENS Model(tens	Electronic Waveform Laboratory, Inc.	GZJ	Class II	1982-03-19
K820582	3M Thinsulate Disposable Hospital Bed	3M Company	KME	Class I	1982-03-18
K820581	Norton Jugular Kits	Norton Performance Plastics Corp.	DYB	Class II	1982-03-18
K820577	Anesthesia Bacteria Filter	Omnicon Medical Corp.	CAH	Class II	1982-03-18
K820576	Mainflow Bacteria Filter	Omnicon Medical Corp.	CAH	Class II	1982-03-18
K820569	Ivac #1160 Multiple Vital Signs Unit	Y	DXN	Class II	1982-03-18
K820527	Anesthesia Extension Tubes	David Simmonds Co., Inc.	FPK	Class II	1982-03-18
K820521	Sterilization Wrap	General Medical Co.	FRG	Class II	1982-03-18
K820484	Venes Custon Rx	Jung Products, Inc.	FQL	Class I	1982-03-18
K820356	Multicor (Gamma) 402 Cardiac Pacer	Cordis US Corp.	DXY	Class III	1982-03-18