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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2253 of 3531

510(k) clearances, page 2253 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925921	Modified Site Disposable Diaphragm Cassette	Site Microsurgical Systems, Inc.	KYG	Class I	1993-12-06
K925643	Rx Fit Medical Stockings	Elastic Therapy, LLC	DWL	Class II	1993-12-06
K924016	Symbiosis Reusable Arthroscopic Surgical Inst.	Boston Scientific Corporation	HRX	Class II	1993-12-06
K923788	Space Labs Model 90560	Spacelabs, Inc.	LOS		1993-12-06
K935016	Cocaine Metabolite Eia Assay Modification	Diagnostic Reagents, Inc.	DIO	Class II	1993-12-03
K934747	R & D Batteries, Inc. Part Numbers 5296, 5479, 5351, & 5470	R & D Batteries, Inc.	JPA	Class II	1993-12-03
K934660	R and D Batteries, Inc. Part Numbers 5310, 5063 & 5211	R & D Batteries, Inc.	DSH	Class II	1993-12-03
K934473	Lactoferrin Microassay System	Touch Scientific, Inc.	DEG	Class I	1993-12-03
K934355	Electromedics Blood Heat Exchanger	Electromedics, Inc.	DTR	Class II	1993-12-03
K932747	Ciba Corning Acs Free T3 Immunoassay	Ciba Corning Diagnostics Corp.	CDP	Class II	1993-12-03
K932715	Ciba Corning Acs Estradiol Immunoassay	Ciba Corning Diagnostics Corp.	CHP	Class I	1993-12-03
K932608	Cobas(r) Core T3 Eia	Roche Diagnostic Systems, Inc.	CDP	Class II	1993-12-03
K932438	Model Ipm-1 Impedance Pulse Monitor	Electro-Diagnostic Instruments	DSB	Class II	1993-12-03
K932389	8100 Anesthetic Agent Monitor	Biochem International, Inc.	CBS	Class II	1993-12-03
K932206	Synelisa Ana Profile	Elias U.S.A., Inc.	LJM	Class II	1993-12-03
K932109	Profilomat	Qmed, Inc.	DXN	Class II	1993-12-03
K930776	Cobas Core Tsh Eia	Roche Diagnostic Systems, Inc.	JLW	Class II	1993-12-03
K925755	De Luxe	Rudolf Riester GmbH & Co. KG	HLJ	Class II	1993-12-03
K925735	EEG Analyzer	Bio-Scan, Inc.	GWS	Class I	1993-12-03
K925593	Nortec Sterile Water for Device Irrigation	North American Sterilization & Packaging Co.	LDQ		1993-12-03
K925588	Nortec Ster Saline-O.9% Sodium Chlor for Dev Irri	North American Sterilization & Packaging Co.	LDQ		1993-12-03
K924626	Novametrix Model 510	Novametrix Medical Systems, Inc.	DQA	Class II	1993-12-03
K922998	Enfuse Enteral Feeding Tube	Rusch, Inc.	KNT	Class II	1993-12-03
K920703	Gastrointestinal Feeding Tube	Wilson-Cook Medical Inc.	KNT	Class II	1993-12-03
K935171	Stabiltrach	B & B Medical Technologies, Inc.	CBH	Class I	1993-12-02
K934830	Hcg Pregnancy One Step Test Strip	Tcpi, Inc.	LCX	Class II	1993-12-02
K934701	Reagents for Cobas Ise Module	Alko Diagnostic Corp.	JIX	Class II	1993-12-02
K934623	Endoscopic Video System and Endoscopic Video Camera	Endomedix	FET	Class II	1993-12-02
K934441	King Systems Hme	King Systems Corporation.	BYD	Class I	1993-12-02
K933048	Laerdal(tm) Pocket Mask, Modification	Laerdal Medical a/S	KGB	Class I	1993-12-02
K932719	Ritter Model 158 and 159 Exam Lights	Midmark Corp	KZF	Class I	1993-12-02
K932479	B-Hcg Human Serum Controls	Pyramid Biological Corp.	JJX	Class I	1993-12-02
K932406	Nuclitryp(tm)(i125)-Human Pancrea Cath Try Rad Kit	Nuclear Diagnostics, Inc.	JNO	Class I	1993-12-02
K932176	Biosil Medical Grade Silicone Sheeting	Bioplexus Corp.	KHJ	Class II	1993-12-02
K931849	Paraprep	Medastat Scientific Corp.	LKS	Class I	1993-12-02
K931626	Carapace Sterile Cotton Balls	Carapace, Inc.	FRL	Class I	1993-12-02
K925858	Oe 1.5 Si	Otsuka Electronics Co., Ltd.	LNH	Class II	1993-12-02
K924461	Strep a Negative Control	Pacific Biotech, Inc.	GTZ	Class I	1993-12-02
K921134	Fresenius Polysulfone Dialyzers	Fresenius USA, Inc.	KDI	Class II	1993-12-02
K915620	Endowash	Novar Medical Industries	FEB	Class II	1993-12-02
K934173	Suture Handler	Surgin Surgical Instrumentation, Inc.	GCJ	Class II	1993-12-01
K934087	Implantable Clip Applier	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1993-12-01
K934075	Isi Metzenbaum Scissors	Innovative Surgical, Inc.	GEI	Class II	1993-12-01
K934035	Gm Monopolar/frazier Suction Probe	Gm Engineering, Inc.	GEI	Class II	1993-12-01
K933866	Acu-Hemostatic Ring	Acuderm, Inc.	MDM	Class I	1993-12-01
K933815	Bard Endoscopic Injection System	C.R. Bard Inc	FBK	Class II	1993-12-01
K932714	Electronic Glove Integrity Monitor (Egim)	Surface Mount Technology, Inc.	LDQ		1993-12-01
K932476	Proximate Reloadable Articulating Linear Stapler	Ethicon Endo-Surgery Inc	GAG	Class II	1993-12-01
K932143	Flexi-Trak Anchoring Device	Convatec, A Division of E.R. Squibb & Sons	KNY	Class II	1993-12-01
K930611	True Flow(tm) Valve	Gm Engineering, Inc.	GEX	Class II	1993-12-01