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 3424 of 3526

510(k) clearances, page 3424 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782047	Processing System, A2 Image	Medtronic, Inc.	IYX	Class I	1978-12-20
K782028	Round Silicone Drain	Davol, Inc.	GCY	Class I	1978-12-20
K782027	Hysterectomy T Drain	Davol, Inc.	JOL	Class II	1978-12-20
K782005	Radiation Oncology System	Philips North America LLC	KPQ	Class II	1978-12-20
K781979	Surgairtome Two	American Sterilizer Co.	HSZ	Class I	1978-12-20
K781977	Applicator, Lee Impression	Lee Pharmaceuticals	EID	Class I	1978-12-20
K781962	Diji-Dent	J&J Technologies, Inc.	EFW	Class I	1978-12-20
K781948	Column Test, Hemoglobin a	Bio-Rad	LCP	Class II	1978-12-20
K781935	Nu-Glaze	Deringer-Ney, Inc.	ELL	Class II	1978-12-20
K781927	Human II Lens	Spectra-Shield, Inc.	HQG	Class I	1978-12-20
K781900	Analyzer, Automed Centrifugal	Autogenic Systems	JJG	Class I	1978-12-20
K781899	Urea Nitrogen Test	Wako Intl., Inc.	CDL	Class II	1978-12-20
K781898	Clearing Solution #Eca01976	Electrophoresis Corp. of America	JQK	Class I	1978-12-20
K781896	Blood Group Substance A,b	North American Biologicals, Inc.	KSX	Class II	1978-12-20
K781895	Blood Group Substance B	North American Biologicals, Inc.	KSX	Class II	1978-12-20
K781893	Control, Protein Electrophoresis	Sigma Chemical Co.	JJY	Class I	1978-12-20
K781885	Serum, Blood Urea Nitiogen	Fisher Scientific Company L.L.C.	CDW	Class II	1978-12-20
K781884	Serum, Creatinine Determinations	Fisher Scientific Company L.L.C.	CGX	Class II	1978-12-20
K781875	Stain Kit for Cell Cultures (30-100-00)	Flow Laboratories, Inc.	KPB	Class I	1978-12-20
K781874	Mycoplasma Arginini Fitc (30-403-41)	Flow Laboratories, Inc.	KPB	Class I	1978-12-20
K781862	Blood Group Substance a	North American Biologicals, Inc.	KSX	Class II	1978-12-20
K781810	Electrosurgical Unit 3001-3009	Halyard Health	GEI	Class II	1978-12-20
K781802	Washer System, Microelisa	Metrix Teknika, Inc.	JTC	Class I	1978-12-20
K781787	Isoplast	Vivadent (USA), Inc.	EBF	Class II	1978-12-20
K781777	Abrasive Wheels	Dentsply Intl.	EJQ	Class I	1978-12-20
K781771	Detector, Model 79875A, Variable	Hewlett-Packard Co.	KIE	Class I	1978-12-20
K781762	Compression Hip Screw System	Howmedica Corp.	KTW	Class II	1978-12-20
K781760	Humidifiers, Model:ls-420 and Ls-460	Bourns Medical Systems, Inc.	BTT	Class II	1978-12-20
K781733	Ria Kit, Preg-Stat	Serono Laboratories, Inc.	JHI	Class II	1978-12-20
K781728	Extube	Analytichem International, Inc.	KEA	Class I	1978-12-20
K781691	Chemstrip Control	Boehringer Mannheim Corp.	JJW	Class I	1978-12-20
K781688	Liner, Cavity Calcium Hydroxide	Kerr Corporation (Danbury)	EJK	Class II	1978-12-20
K781682	Surgical Gowns & Drapes	Kimberly-Clark Corporation	FYA	Class II	1978-12-20
K781638	Rubindex*direct System	Ortho Diagnostics, Inc.	GOK	Class II	1978-12-20
K781632	Urotron	Boehringer Mannheim Corp.	JJQ	Class I	1978-12-20
K781567	Api Zym	Analytical Products, Inc.	JTO	Class I	1978-12-20
K781464	Hemodialyzer, Model Rp610, Rp an 69	Hospal Medical Corp.	KDI	Class II	1978-12-20
K780527	Cortral I	Hospal Medical Corp.	KDI	Class II	1978-12-20
K781963	Electrodes, Offset and Dx	Graphic Controls Corp.	DRX	Class II	1978-12-19
K781864	Adapter Kit	Daig Corp.	DTD	Class II	1978-12-19
K781158	Alarm Unit, Battery Operated	Thompson Respiration Products, Inc.	BZQ	Class II	1978-12-18
K782071	Catheter, Usci Gruntzig/balloon	C.R. Bard Inc	DYG	Class II	1978-12-15
K782053	Hearing Aid, Post-Auricular	Hc Electronics	ESD	Class I	1978-12-15
K782033	Cardiac Care Q/c Test Kit	Instrumentation Laboratory Co.	DRL	Class II	1978-12-15
K782006	Medgeneral Single-Use Bulldog	Med General	GDJ	Class I	1978-12-15
K782004	Lead, Timed Pacing, Implantable	Daig Corp.	DTB	Class III	1978-12-15
K782002	Trach-Collar	KCI USA, Inc.	EQN	Class II	1978-12-15
K781989	Omniprep	Weaver & Co.	GYB	Class II	1978-12-15
K781877	Underpads, High Absorbant Polymer	Bridgewater Mfg. Corp.	KMF	Class I	1978-12-15
K781831	Spirometer, Incentive Catalog # 1750	Hudson Oxygen Therapy Sales Co.	BWF	Class II	1978-12-15