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 3411 of 3526

510(k) clearances, page 3411 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790691	25-50 EKG Ruler	Medical Engineering Designs Co., Inc.	DPS	Class II	1979-04-16
K790462	Medtronic Model 6972	Medtronic, Inc.	DTB	Class III	1979-04-16
K790681	Siemens-Elema A.b. Servo Humidifier 150	Siemens Corp.	BYD	Class I	1979-04-13
K790575	Tube, Armored Tracheal	National Patent Development Corp.	BTR	Class II	1979-04-13
K790199	Ventilator Model Bv-300 Infant	Bourns Medical Systems, Inc.	CBK	Class II	1979-04-13
K790705	Antiserum to Human Igm	Kent Laboratories, Inc.	DAO	Class II	1979-04-12
K790704	Antiserum to Human Igg	Kent Laboratories, Inc.	DEW	Class II	1979-04-12
K790703	Antiserum, Human, Iga	Kent Laboratories, Inc.	CZP	Class II	1979-04-12
K790661	Protector II	Richard-Allan Medical Ind., Inc.	MMK	Class II	1979-04-12
K790660	Surgical Ruler	Richard-Allan Medical Ind., Inc.	FTY	Class I	1979-04-12
K790564	Adapter-Straight	Dlp, Inc.	DTL	Class II	1979-04-12
K790563	Adapters-Y-Type	Dlp, Inc.	DTL	Class II	1979-04-12
K790465	Knee Compression Hook System	Zimmer GmbH	KWP	Class II	1979-04-12
K790340	Delta-Rol	Johnson & Johnson Professionals, Inc.	GCO	Class II	1979-04-12
K790296	Electrode, Model E7504 Prep II	Medtronic, Inc.	GEI	Class II	1979-04-12
K790293	Cimarron 1000 or 1000-2	Cimarron Instruments, Inc.	GEI	Class II	1979-04-12
K790212	Cordia T	Cordis US Corp.	GOL	Class II	1979-04-12
K790682	Tonotest Blood Pressure Device	Robert Bosch Corp.			1979-04-11
K790448	Easyfil	General Refineries, Inc.	EJJ	Class II	1979-04-11
K790651	Model Wc-3 Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1979-04-10
K790634	Impervious Sterile Stockinette	Anago, Inc.	KKX	Class II	1979-04-10
K790609	Audiometer	Grason-Stadler, Inc.	EWO	Class II	1979-04-10
K790572	Lounge, Tilt-a-Body Stretch	Innovative Products, Inc.	ION	Class I	1979-04-10
K790560	Rollchair, Ortho Bucket Seat	Maddak, Inc.	INM	Class I	1979-04-10
K790554	Exeter Lip Seal	Exeter Medical Labs, Inc.	LFA	Unclassified	1979-04-10
K790539	Hearing Aid Danavox 775V	Danavox, Inc.	ESD	Class I	1979-04-10
K790521	Oreia - Digoxin	Organon LLC	KXT	Class II	1979-04-10
K790508	Trapezio-Metacarpal Joint Spacer	Scientific Data Systems Israel, Ltd.	KYI	Class II	1979-04-10
K790501	Pediatric Osteotomy System	Howmedica Corp.	KTT	Class II	1979-04-10
K790497	Bacteriological Culture Media	Micro Media Laboratories	JSG	Class I	1979-04-10
K790439	Contact Resin	Vivadent (USA), Inc.	EBF	Class II	1979-04-10
K790438	Colorant	Vivadent (USA), Inc.	EBD	Class II	1979-04-10
K790416	Diatek 500	Diatek, Inc.	FLL	Class II	1979-04-10
K790414	Development No. 647	Deringer-Ney, Inc.	EJT	Class II	1979-04-10
K790384	Kimlon Bedgard Underpad	Kimberly-Clark Corporation	KMF	Class I	1979-04-10
K790379	Sep-T-Vac Suction Cannister W/ Tubing	Sherwood Medical Co.	KDQ	Class II	1979-04-10
K790378	Reynolds Bleaching Process	Reynolds Laboratories	EEG	Class I	1979-04-10
K790374	Gillette Heat Wrap	The Gillette Company	IRT	Class II	1979-04-10
K790373	Ivac 630 Volumetric Infusion Pump	Y	FRN	Class II	1979-04-10
K790332	Model Iv6000 Infusion Pump	Medtronic, Inc.	FRN	Class II	1979-04-10
K790291	Operating Room Specimen Container	Sage Products LLC	FMH	Class I	1979-04-10
K790290	Ney Equi-Hinge	Deringer-Ney, Inc.	ECG	Class I	1979-04-10
K790254	Foley Catheterization Tray	Snyder Laboratories, Inc.	FCM	Class II	1979-04-10
K790253	Urinary Drainage Bag	Snyder Laboratories, Inc.	KNX	Class II	1979-04-10
K790067	Flow Dialyzer, Cf 2300 Capillary	Travenol Laboratories, S.A.	FJI	Class II	1979-04-10
K790062	IV Administration Set with Backcheck	National Patent Development Corp.	FPA	Class II	1979-04-10
K790506	Daiscope & Accessories	Simonsen & Weels Eftf.	DRT	Class II	1979-04-09
K790450	Novatec Prm	Novatec, Inc.	JOM	Class II	1979-04-06
K790283	Pillow, Carter Arm Elevation	Depuy, Inc.	KME	Class I	1979-04-06
K790502	Dyonics Sterotoxic Positioner	Dyonics, Inc.	HAW	Class II	1979-04-05