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 2900 of 3529

510(k) clearances, page 2900 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860743	Carotid Bypass Shunt with Sampling Arm	Clincal Instruments Corp.	DWF	Class II	1986-05-28
K860742	Carotid Bypass Shunt	Clincal Instruments Corp.	DWF	Class II	1986-05-28
K860702	Sarns Filtered Cardiotomy Reservoir	3M Health Care, Sarns	DTP	Class II	1986-05-28
K860573	Implant Prog Pulse Generator, Unipolar & Bipolar	Telectronics, Inc.	DXY	Class III	1986-05-28
K860497	Carotid Balloon Shunt	Imodex, Inc.	DWF	Class II	1986-05-28
K861834	Theracushion Model 1000	General Physiotherapy, Inc.	ISA	Class I	1986-05-27
K861729	Sprint (Power Drive Wheelchair)	Everest & Jennings, Inc.	ITI	Class II	1986-05-27
K861728	Rionet Hearing Aid	Rion Acoustic Instruments, Inc.	ESD	Class I	1986-05-27
K861669	Sodium, Potassium and Chloride Procedure	Data Medical Associates, Inc.	CGZ	Class II	1986-05-27
K861668	Magnesium Procedure	Data Medical Associates, Inc.	JGJ	Class I	1986-05-27
K861632	Sims Chair	Twin City Surgical, Inc.	IKK	Class II	1986-05-27
K861622	Sagittal & Rotary Act/pass Knee Ligament Tester	Mizuho Orthopedic Systems Inc	IKK	Class II	1986-05-27
K861523	Standard Blood Transfusion Filter Set (Code 1025)	Jufrey Multimed Corp.	BRZ	Class II	1986-05-27
K861521	Universal Disposable Infusion Set (Code 0330)	Jufrey Multimed Corp.	FPA	Class II	1986-05-27
K861520	Universal Disposable Infusion Set (Code 0205)	Jufrey Multimed Corp.	FPA	Class II	1986-05-27
K861519	Universal Disposable Infusion Set (Code 0330F)	Jufrey Multimed Corp.	FPA	Class II	1986-05-27
K861518	Universal Disposable Infusion Set (Code 0205F)	Jufrey Multimed Corp.	FPA	Class II	1986-05-27
K861496	Stockert-Shiley Venous Cath & Aortic Arch Cannula	Shiley, Inc.	DWF	Class II	1986-05-27
K861344	R1124 & R1686 Paraffin	Tri W-G, Inc.	IMC	Class II	1986-05-27
K860857	Sof Set, Models 113 and 114	Pacesetter Systems	FRN	Class II	1986-05-27
K860361	Diasonics 3.5 Gwa 30Mm Probe	Diasonics, Inc.	ITX	Class II	1986-05-27
K860281	Convex Probe, Pve-382M	Toshiba Medical Systems	ITX	Class II	1986-05-27
K854631	Assert Eo Biological Test Pack	Surgicot, Inc.	FRC	Class II	1986-05-27
K861807	Medcare Hemostats (Straight, Curved, Mosquito-Tip)	Medcomp Technologies, Inc.	HRQ	Class I	1986-05-23
K861806	Medcare Suture Scissors (Suture/gauze Weight)	Medcomp Technologies, Inc.	KDA	Class II	1986-05-23
K861805	Medcare Forceps (Thumb, Tissue)	Medcomp Technologies, Inc.	GEN	Class I	1986-05-23
K861804	Medcare Suture Removal Kit	Medcomp Technologies, Inc.			1986-05-23
K861755	Shs Cushion/wheelchair	Special Health Systems, Ltd.	KNN	Class I	1986-05-23
K861754	Kinesethetic Seating System/wheelchair	Special Health Systems, Ltd.	KNN	Class I	1986-05-23
K861751	The Fitz Kit, Molded/custom Wheelchair Seating Sys	Special Health Systems, Ltd.	KNN	Class I	1986-05-23
K861749	3X Blue Panoramic Loupes 13.5 Working Distance	Keeler Instruments, Inc.	FSP	Class I	1986-05-23
K861713	Serum Potassium Reagent Set	Sterling Diagnostics, Inc.	CEJ	Class II	1986-05-23
K861653	Glucose Hk Procedure	Data Medical Associates, Inc.	CGA	Class II	1986-05-23
K861640	Modumatic (R) Diluter	Tri-Continent Scientific, Inc.	JQW	Class I	1986-05-23
K861633	Liquid Chromatography Columns	Supelco, Inc.	DPM	Class I	1986-05-23
K861615	Salicylate Reagent Set	Sterling Diagnostics, Inc.	DKJ	Class II	1986-05-23
K861603	Iron Procedure	Data Medical Associates, Inc.	JJY	Class I	1986-05-23
K861602	Total Iron Binding Capacity Procedure	Data Medical Associates, Inc.	CFM	Class I	1986-05-23
K861591	Weck-Lube, Catalog No. 850-150	Palmetto Chemical & Supply Co., Inc.			1986-05-23
K861589	Weck-Kreem, Catalog No. 850-155	Palmetto Chemical & Supply Co., Inc.			1986-05-23
K861567	Control Sera Level Values (Mg/dl)	E.I. Dupont de Nemours & Co., Inc.	JJY	Class I	1986-05-23
K861531	Disposable Surgical Drapes and Accessories	Medical Concepts Development, Inc.	KKX	Class II	1986-05-23
K861512	Emds, Ck/ck-Mb Verifier, Item Number 67---/95	Em Diagnostic Systems, Inc.	JJT	Class I	1986-05-23
K861467	Albumin (Bcg) Reagent	Sigma Diagnostics, Inc.	CIX	Class II	1986-05-23
K861412	Direct Readout Module Accessory	E.I. Dupont de Nemours & Co., Inc.	JQP	Class I	1986-05-23
K861262	Mms T3 Uptake	Micromedic Systems	KHQ	Class II	1986-05-23
K861250	Mesulin, Insulin Infusion Set	Molnlycke A/S Hospital Products	FPA	Class II	1986-05-23
K861185	Therachem-Plus, Tri-Level Tdc (Tm)	Fisher Scientific Company L.L.C.	JJY	Class I	1986-05-23
K860983	Interpore 200 Porous Hydroxyapatite	Interpore Intl.	LYC	Class II	1986-05-23
K860942	Quantimetrix Human Bilirubin Control I & II Liquid	Quantimetrix Corp.	JJY	Class I	1986-05-23