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 3415 of 3526

510(k) clearances, page 3415 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790196	Monoject Arterial Blood Sampling Device	Sherwood Medical Industries	CBT	Class I	1979-03-13
K790204	Plasma, Standardized Normal	Dade, Baxter Travenol Diagnostics, Inc.	JPA	Class II	1979-03-12
K790197	Reagent Kit, Lancer Glucose	Sherwood Medical Industries	JJF	Class I	1979-03-12
K790151	One-Way Valve	Airlife, Inc.	CBP	Class II	1979-03-12
K790138	Choric-Shure	Nuclear Medical Laboratories, Inc.	JHI	Class II	1979-03-12
K790103	Nephelometer, Mic-2000 Laser	Dynatech Corp.	JQX	Class I	1979-03-12
K790092	Uric Acid, Bound Enzyme	Technicon Instruments Corp.	KNK	Class I	1979-03-12
K790088	Aca Creatine Kinase Isoenzymes	E.I. Dupont de Nemours & Co., Inc.	JHS	Class II	1979-03-12
K790003	Ria Kit, Prolactin	Cis Radiopharmaceuticals, Inc.	CFT	Class I	1979-03-12
K782129	Lupo-Tec	Armkel, LLC	DHC	Class II	1979-03-12
K790356	Oxygenator, Cobe Catalog #42-220	Cobe Laboratories, Inc.	DTZ	Class II	1979-03-09
K790285	Imager, Pho/sonic Series 2000	G.D. Searle and Co.	IYO	Class II	1979-03-08
K790239	Phytohaemagglutinin	Pharmacia Fine Chemicals	KIQ	Class I	1979-03-08
K790119	C/n Screen	Corning Medical & Scientific	JSI	Class I	1979-03-08
K782164	Stimulator, Model 1-600 Electric Nervr	Ipco Corp.	GZJ	Class II	1979-03-08
K790334	Drager Orm	Draeger, Inc.	BYR	Class I	1979-03-07
K790154	Manifold, for Double Supply	Airlife, Inc.	CAF	Class II	1979-03-07
K790153	Manifold, W/corrugated Tubing	Airlife, Inc.	CAF	Class II	1979-03-07
K790152	Manifold, Universal I.p.p.b	Airlife, Inc.	CAF	Class II	1979-03-07
K790355	Model 342D Hearing Aids	Telex Communications, Inc.	ESD	Class I	1979-03-06
K790354	Model 342 Hearing Aids	Telex Communications, Inc.	ESD	Class I	1979-03-06
K790350	Posterior Cruciate Condylar Tibial	Howmedica Corp.	HRY	Class II	1979-03-06
K790349	Total Condylar Knee Prosthesis	Howmedica Corp.	HRY	Class II	1979-03-06
K790348	Anametric Tibial Component Metal Tray	Howmedica Corp.	HRY	Class II	1979-03-06
K790314	Fluid Administration Sets, 15 Micron	Medex, Inc.	FPB	Class II	1979-03-06
K790279	Catheter, Mmg Latex External	Medical Marketing Group	KNX	Class II	1979-03-06
K790272	Tray, Urethral Catheterization	Snyder Laboratories, Inc.	FCM	Class II	1979-03-06
K790271	Tray and Bag, Catheterization	Snyder Laboratories, Inc.	FCM	Class II	1979-03-06
K790198	Monitor Plug-in Model M1106 ECG	Electronics for Medicine, Inc.	DRT	Class II	1979-03-06
K790137	Infant Care System	Narco Air-Shields	FMT	Class II	1979-03-06
K790108	Filterset 0.22, i.v. Pump	Imed Corp.	FPA	Class II	1979-03-06
K790089	Tape Measure	Pfizer Inc	FTY	Class I	1979-03-06
K790001	Dialyzer, Model F.m.d 150	Hospal Medical Corp.	FJG	Class II	1979-03-06
K781901	Kanga Pants	H.A. & J.E. Wood, Inc.	EYQ	Class I	1979-03-06
K781772	Catheter, Transluminal Balloon	Medi-Tech, Inc.	GBA	Class I	1979-03-06
K790367	Grab-It	Concept, Inc.	GEI	Class II	1979-03-02
K790328	Model 1051, Monitor	Applied Medical Research	DXN	Class II	1979-03-02
K790325	Reprodent	Premier Dental Products Co	EBI	Class II	1979-03-02
K790256	Emit Theophylline Assay	Syva Co.	KLS	Class II	1979-03-02
K790255	Emit AED Assays 3500 Computer Directed	Syva Co.	KLT	Class II	1979-03-02
K790246	Sarns Wire-Reinforced Venous Return Can	3M Health Care, Sarns	DWF	Class II	1979-03-02
K790203	Interval Timer Model V4295	Electronics for Medicine, Inc.	DRR	Class II	1979-03-02
K790133	Spinsep-Fe59	Nuclear Diagnostics, Inc.	JQG	Class I	1979-03-02
K790036	Digital Bpm	Narco Air-Shields	DXO	Class II	1979-03-02
K790011	Stimulator, Mentor 100 Nerve	Mentor	GZJ	Class II	1979-03-02
K782156	Unitest Creatine Kinase	Boehringer Mannheim Corp.	JLB	Class I	1979-03-02
K782128	Thera Chem	Fisher Scientific Company L.L.C.	DIF	Class I	1979-03-02
K782032	Unitest Amylase	Boehringer Mannheim Corp.	CIW	Class II	1979-03-02
K782009	Ria Kit, Progesterone	The Upjohn Co.	JLS	Class I	1979-03-02
K782163	The Blue Mask	Collectovac, Inc.	BSJ	Class I	1979-03-01