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 1501 of 3531

510(k) clearances, page 1501 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K010401	Tri-Plex Adapter	The Medical Device Group, Inc.	MOD	Class II	2002-10-30
K023471	Disetronic H-Tronplus Insulin Infusion Pump	Disetronic Medical Systems	LZG	Class II	2002-10-29
K023323	1Cc Futura Safety Syringe	Futura Medical Technology	MEG	Class II	2002-10-29
K023303	Export Aspiration Catheter	Medtronic, Inc.	NFA	Class II	2002-10-29
K022626	Moisturestay (Revlon)	Raymond Industrial, Ltd.	IMC	Class II	2002-10-29
K022615	Centerpulse, Spine-Tech Division Cement Restrictor	Centerpulse Spine-Tech, Inc.	JDK	Class II	2002-10-29
K022194	Traxx Electric Wheelchair	Crossroads Distribution Company, LLC	ITI	Class II	2002-10-29
K020641	Spiritus(tm) Respiratory System #Srs 001	Worldwide Medical Technologies, LLC	BZD	Class II	2002-10-29
K023368	Trucath.ip	Aortech Critical Care, Ltd.	DFG	Class II	2002-10-28
K023343	Environ-Np Disposable Synthetic Vinyl Exam Gloves, Powdered	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	2002-10-28
K023300	Hi-Torque Whisper Ls; Hi-Torque Whisper Ms; Hi-Torque Whisper Ms Cs-J; Hi-Torque Whisper Es; Hi-Torque Whisper Es Cs-J	Boston Scientific Corporation	DQX	Class II	2002-10-28
K023262	Powder-Free Latex Examination Glove with Protein Labeling Claim (200 Microgram per Gram of Glove or Less)	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	2002-10-28
K023042	Pq1	Ultradent Products Inc.	KLE	Class II	2002-10-28
K022941	Medisense Precision Pcx Point of Care Management System for Blood Glucose Testing	Abbott Medical	LFR	Class II	2002-10-28
K022653	Elite Monophase	Zhermack S.p.A.	ELW	Class II	2002-10-28
K022612	Ibond Gluma Inside	Kulzer GmbH	KLE	Class II	2002-10-28
K022589	Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device	Acon Laboratories, Inc.	LAF	Class II	2002-10-28
K021635	Karats Multipurpose Solution	Alcon Laboratories	LPN	Class II	2002-10-28
K021541	Neogram Pku Tandem Mass Spectrometry Kit	Revvity Health Sciences, Inc.	JNB	Class II	2002-10-28
K021210	Arteria Occlusion Balloon	Arteria Medical Science, Inc.	MJN	Class II	2002-10-28
K023428	Vinyl Examination Glove, Powder-Free, White	Shanghai Jiawang Industrial Co., Ltd.	LZA	Class I	2002-10-25
K023420	Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, Reacteb	Medical Electronic Devices, Inc.	NFB	Class II	2002-10-25
K023399	Ebi Xfix Dfs System	Ebi, LLC	KTT	Class II	2002-10-25
K023375	Modification to Esop Co-Cr Femoral Heads	Pro-Active Healthcare	LPH	Class II	2002-10-25
K023360	Leforte System Bone Plate	Jeil Medical Corporation	KTW	Class II	2002-10-25
K023302	Echelon Porous Plus Ha Hip Stems	Smith & Nephew, Inc.	MEH	Class II	2002-10-25
K023224	Infusion Catheter Extension Set	Chf Solutions, Inc.	KDI	Class II	2002-10-25
K023220	Varisource Breast Template System	Varian Medical Systems, Inc.	JAQ	Class II	2002-10-25
K023217	Modification to Smart Control Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2002-10-25
K023002	Clearfil Ap-X Plt	Kuraray Medical, Inc.	EBF	Class II	2002-10-25
K022938	Vizdexter Version 2.0; Dextroscope Mk8; Dextrobeam Mk3	Volume Interactions Pte, Ltd.	LLZ	Class II	2002-10-25
K022788	Philips Harmony Release 1	Philips North America LLC	LLZ	Class II	2002-10-25
K022739	Real Time Hdr (220V), Model 132.001; Real Time Hdr (110V), Model 132.002	Nucletron BV	JAQ	Class II	2002-10-25
K022706	Spsmedical Sporview Steam Bi Test Pack	Spsmedical Supply Corp.	FRC	Class II	2002-10-25
K022613	Helix Hydro-Jet	Erbe USA Inc	FQH	Class II	2002-10-25
K022604	Powder Free Elastic Vinyl Examination Gloves	Sun Flower Gloves Co., Ltd.	LYZ	Class I	2002-10-25
K022513	Medcomp Vascu-Sheath Introducer Set	Medcomp	DYB	Class II	2002-10-25
K022503	Uterine Injector	Thomas Medical, Inc.	LKF	Class II	2002-10-25
K022484	Cook Injection Needle	Cook Incorporated	FBK	Class II	2002-10-25
K022477	Summit Medical Ltd Transfusion Filter, Model Lf400 & Summit Medical Ltd Transfusion Filter with Administration Set	Summit Medical, LLC	CAK	Class II	2002-10-25
K022356	Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay	Nichols Institute Diagnostics	LYR	Class I	2002-10-25
K022268	Horizons Reusable Polypectomy Snares	Horizons Intl. Corp.	FDI	Class II	2002-10-25
K022243	Horizons Reusable Hot Biopsy Forceps	Horizons Intl. Corp.	KGE	Class II	2002-10-25
K021976	Fibron-1, Fibron-4, Quikcoag, Fibron	VitalScientific	KQG	Class II	2002-10-25
K021854	Dfv Cpg Colposcope	D.F. Vasconcellos S.A.	HEX	Class II	2002-10-25
K021742	Galemed Neb-Easy Nebulizer	Galemed Corp.	CAF	Class II	2002-10-25
K021728	Ringloc Constrained Liners II	Zimmer GmbH	KWZ	Class II	2002-10-25
K021661	Ringloc Constrained Liners	Biomet Orthopedics, Inc.	KWZ	Class II	2002-10-25
K021630	Boston Scientific Express Biliary Ld Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2002-10-25
K021564	Incompass Spinal Fixation System	Spinal Concepts, Inc.	KWQ	Class II	2002-10-25