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 2325 of 3531

510(k) clearances, page 2325 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924918	Force Gsu Handset W/laparoscopic Electrode (28Cm)	Medtronic, Inc.	GEI	Class II	1993-01-29
K924477	Wipeable Pillow	Perfect Fit Industries, Inc.	FMW	Class I	1993-01-29
K923799	Smoke Eater	Nordex Medical Corp.	FYD	Class II	1993-01-29
K923753	Able Generation Therapy Tilt Bench	The Able Generation, Inc.	INN	Class I	1993-01-29
K923752	Able Generation Play Chair	The Able Generation, Inc.	INN	Class I	1993-01-29
K923751	Able Generation Desk	The Able Generation, Inc.	INW	Class I	1993-01-29
K923750	Able Generation Booster Chair	The Able Generation, Inc.	INN	Class I	1993-01-29
K923576	Sterile Natural Rubber Latex Surgions' Gloves	Mri Corp.	KGO	Class I	1993-01-29
K923188	Dynasty Impervious Isolation J-Suit	Dynatech Medical Products	FYC	Class II	1993-01-29
K923187	Impervious Isolation Shoe Covers	Dynatech Medical Products	FXW	Class I	1993-01-29
K922802	Microsurge Front-End Grasping Devices	Microsurge, Inc.	GEI	Class II	1993-01-29
K922669	Multidop Model Hd-2020 Bi-Directional Blood Flow	Koven and Assoc., Inc.	DPW	Class II	1993-01-29
K922083	Rmi Surgiccal Site Visualization Wand	Research Medical, Inc.	FQH	Class II	1993-01-29
K921955	Quik Flow	California Medical Equipment, Inc.	FOZ	Class II	1993-01-29
K921613	Sterilizer, Surg Instr/dressing #6530-01-306-9510	Dept. of the Army	FLE	Class II	1993-01-29
K915824	Hole Punch	American Biomaterials Corp.	FOZ	Class II	1993-01-29
K914702	Sterile View(tm) Knee-High Boots/depuy Shoe Boots	Depuy, Inc.	FXP	Class I	1993-01-29
K926518	Ise Calibrator for Dupont Dimension	Alko Diagnostic Corp.	JIX	Class II	1993-01-28
K926359	Clinitek 200+ Urine Chemistry Analyzer	Kulzer GmbH	KQO	Class I	1993-01-28
K925898	Model 19 Stimulator, Nerve, Transcutaneous	Staodyne, Inc.	GZJ	Class II	1993-01-28
K925535	Cardiobeeper(r) Cb-Iia	Survival Technology, Inc.	DXH	Class II	1993-01-28
K925479	Sugar Chex Linearity for the One Touch	Streck Laboratories, Inc.	JJX	Class I	1993-01-28
K925409	Oral-B Dental Floss with Fluoride	Oral-B Laboratories	JES	Class I	1993-01-28
K925408	Oral-B Dental Tape with Fluoride	Oral-B Laboratories	JES	Class I	1993-01-28
K925383	Photo Clearfil Opaquer	Kuraray Co.	EBF	Class II	1993-01-28
K925364	Mridian Medical Systems Ventlator Hoses	Merit Medical Systems, Inc.	BZQ	Class II	1993-01-28
K925330	System, Tomographic, Nuclear	Rjl Associates, LLC	KPS	Class II	1993-01-28
K924901	Deans Disposable T-Tube Inserter	Exmoor Plastics Limited	JYM	Class I	1993-01-28
K924547	Nova 8 Crt Analyzer	Nova Biomedical Corporation	JGS	Class II	1993-01-28
K924508	Cholesterol Test Item# 42374/93, 42322/R1	Em Diagnostic Systems, Inc.	CHH	Class I	1993-01-28
K924021	Power Supply	The Binding Site	JJN	Class I	1993-01-28
K923822	Autolith-Iehl	Northgate Technologies Inc.	FFK	Class II	1993-01-28
K922779	Implant-Prophy & Plastic Dental Instrument System	Advanced Implant Technologies, Inc.	DZE	Class II	1993-01-28
K922294	Perikon Pcl 90	Optikon Oftalmologia SpA	HPT	Class I	1993-01-28
K920674	Electrolink	Kold Products	GXY	Class II	1993-01-28
K920671	Digi -Flow	D and D Technology, Inc.	KOC	Class II	1993-01-28
K920389	Rs-2 Neuromuscular Stimulator	RS Medical	IPF	Class II	1993-01-28
K920388	Rs-1 Neuromuscular Stimulator	RS Medical	IPF	Class II	1993-01-28
K920273	Hemovac Autotransfusion System	Zimmer Patient Care Division	CAC	Class II	1993-01-28
K914583	Tosbee	Toshiba America Medical Systems, In.C	IYD	Class II	1993-01-28
K926442	Premier C. Difficile, Modification	Meridian Diagnostics, Inc.	LLH	Class I	1993-01-27
K926244	Widex Model D8 (Hearing Aid)	Widex Hearing Aid Co., Inc.	ESD	Class I	1993-01-27
K926144	Urine Magnesium Method for Technicon Chem Systems	Kulzer GmbH	JGJ	Class I	1993-01-27
K925913	Access(r) Free T4 Assay	Bio-Rad Laboratories Inc.	CEC	Class II	1993-01-27
K925465	Teleradiology Device & Component of Pacs Component	Life Care Imaging	LLZ	Class II	1993-01-27
K924787	Burton Slit Lamp	R.H. Burton Co.	HJO	Class II	1993-01-27
K924782	Burton Slit Lamp - Model 2000	R.H. Burton Co.	HJO	Class II	1993-01-27
K924770	Burton Hand Held Slit Lamp - Model Sl750	R.H. Burton Co.	HJO	Class II	1993-01-27
K924637	Hemochron Citra Onestep Aptt/fac VI Singshot Aptt	Accriva Diagnostics, Inc.	GFO	Class II	1993-01-27
K924633	Hypoallergenic Latex Gloves	Pan-Century Rubber Products Sdn. Bhd.	LYY	Class I	1993-01-27