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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2935 of 3529

510(k) clearances, page 2935 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854814	Surgical Cauteries Models 775-11,12,13,31,32 & 33	Birtcher Corp.	GEI	Class II	1986-01-13
K854809	White Cross Sterile Pad 4In. X 4In.	American White Cross, Inc.			1986-01-13
K854789	Range-Chek	American Monitor Corp.	JJY	Class I	1986-01-13
K854768	Terumo Sensibead Eia Hprl Kit	Terumo Medical Corp.	CFT	Class I	1986-01-13
K854595	P.a. Medical Vaginal Irrigation Set #1130	Pa Medical Corp.	HED	Class I	1986-01-13
K854582	Mod Target/tips # 4011,4012,4511,4512,6912,4016	Medtronic, Inc.	DTB	Class III	1986-01-13
K854294	Medsurg Seldinger Needle	Medsurg Industries, Inc.	DRC	Class II	1986-01-13
K854175	Defigard 2000	Odam	LDD	Class II	1986-01-13
K854164	Cruiser	Invacare GmbH	ITI	Class II	1986-01-13
K854117	Amendment Lifepak 8, Npn 052	Physio Control, Inc.	DRO	Class II	1986-01-13
K854059	Micro-Elisa Hcg Est Kit Visi-Check Hcg Test Kit No	Bioclinical Systems, Inc.	JHI	Class II	1986-01-13
K853918	The Sportster (Electrified Wheelchair)	Amigo Sales, Inc.	INI	Class II	1986-01-13
K853749	Custom Coronary Manifold Kits	Procedure Products, Inc.	DTL	Class II	1986-01-13
K853714	Pharmaseal Over-the Needle Arterial Catheter & Sta	American Pharmaseal Div. Ahsc	DQY	Class II	1986-01-13
K853705	Bomed-Eea	Bomed Medical Mfr., Ltd.	DRX	Class II	1986-01-13
K853446	Polysafe Ccs Trifix Endocardial Pacing Lead Sv-107	Cardiac Control Systems, Inc.	DTB	Class III	1986-01-13
K853018	Model 3000 Opticath Computer	Oximetrix, Inc.	DXG	Class II	1986-01-13
K853008	Sonoline Sl-2(Ultrasound Scanner)	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-01-13
K860023	Compact 2000 Water Seal Chest Drainage Unit	Atrium Medical Corporation	KDQ	Class II	1986-01-10
K855219	Kodak Rp X-Omat Processor Model M6b	Eastman Kodak Company	IXW	Class II	1986-01-10
K855213	Pet-Scope II Image Intensifier	Philips North America LLC	JAA	Class II	1986-01-10
K855209	Nir Lat Male External Catheter	Mali, Inc.	KNX	Class II	1986-01-10
K855058	Evds, Evmds, Lds & Ivmcs Central Nervous Sys Fluid	Cordis US Corp.	JXG	Class II	1986-01-10
K855043	3M Dry Silver Imager	3M Company	LMC	Class II	1986-01-10
K854880	Radiation Beam Data Acquistioin Systems	Elekta Limited	KPQ	Class II	1986-01-10
K854745	Custo Vit Pulmonary Function Analysis System	Versacor, Inc.	BTY	Class II	1986-01-10
K854601	Spring Guide Catheter Anesthesia Conduction Cath	Concord Laboratories, Inc.	BSO	Class II	1986-01-10
K854486	Table,radiographic-Fluoroscopic,tomographic,remote	Absolute X-Ray Corp.	IXR	Class II	1986-01-10
K854320	Ackrad Oral Suction Tube	Ackrad Laboratories	BSY	Class I	1986-01-10
K854204	Dynex Reusable, Self-Adhering Electrode W/tens	La Jolla Technology, Inc.	GXY	Class II	1986-01-10
K854160	Cns-16 & Ltm 1.0 Software	Cns, Inc.	GWS	Class I	1986-01-10
K853683	Ums-100	Narco Bio-Systems	FAP	Class II	1986-01-10
K853671	Beamscan	Victoreen, Inc.	KPQ	Class II	1986-01-10
K853059	Laborie Fiberoptic Pressure Sensor & Interface	Tridak Division of Indicon, Inc.	FAP	Class II	1986-01-10
K852842	Selectron Hdr Remote Afterloader	Nucletron-Oldelft Corp.	JAQ	Class II	1986-01-10
K854966	Acute Peritoneal Dialysis Catheters	Thermedics, Inc.	FKO	Class II	1986-01-09
K854800	Norelco Digital Thermometer, Model Ht 960	Philips Park	FLL	Class II	1986-01-09
K854628	Churchill-Hcm Vented IV Set	Churchill Corp.	FPA	Class II	1986-01-09
K854562	Connector, Blood Tubing, Infusion T. Intravenous I	Medelec Intl. Corp.	BRZ	Class II	1986-01-09
K854446	Terumo Terufusion Blood & Y-Type Admin. Set	Terumo Medical Corp.	FPA	Class II	1986-01-09
K854040	i.v. Dressing	Consolidated Medical Equipment Company	KMK	Class I	1986-01-09
K853902	Endo-Lase Cd40 for Otorhinolaryngology	Endo Lase, Inc.	EWG	Class II	1986-01-09
K853875	Endo-Lase Cd-100 CO2 Laser for Otorhinolaryngology	Endo Lase, Inc.	EWG	Class II	1986-01-09
K853843	IV Mate	Medtech Intl., Inc.	FLN	Class II	1986-01-09
K853348	L-Cath Expando Cath	Luther Medical Products, Inc.	FOZ	Class II	1986-01-09
K851293	Implantofix	Burron Medical Products, Inc.	LJT	Class II	1986-01-09
K850855	TENS Gb1001 Device	Medicon Co., Ltd.	GZJ	Class II	1986-01-09
K855121	Coloshield Kit	Deknatel, Inc.	KNT	Class II	1986-01-08
K854951	Plume Y Set	Hospal Medical Corp.	FIE	Class II	1986-01-08
K854523	Analyst Physician's Office Profiler	E.I. Dupont de Nemours & Co., Inc.	JJG	Class I	1986-01-08