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 1281 of 3531

510(k) clearances, page 1281 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052954	Contistim Continuous Stimulating Catheter Nerve Block Set	Life-Tech, Inc.	CAZ	Class II	2006-02-15
K052882	Forsure Rapid One Step Multiple(x) Abuse Drug Screen Test Cup Device	Tianjin New Bay Bioresearch Co., Ltd.	DKZ	Class II	2006-02-15
K052833	Gore-Tex Non-Sterile Surgical Gowns	MEDLINE INDUSTRIES, LP - Northfield	KKX	Class II	2006-02-15
K052321	Versys Epoch Fullcoat Hip Prosthesis	Zimmer GmbH	LPH	Class II	2006-02-15
K052204	The Elite - Ultra-Light, Compact Portable Scooter	Tzora Active Systems, Ltd.	INI	Class II	2006-02-15
K051295	I-D Glide	WESTRIDGE LABORATORIES, Inc	NUC	Class II	2006-02-15
K060123	Levelert II Fluid Level Sensor	Smith & Nephew, Inc.	FLN	Class II	2006-02-14
K060042	Landlex, Model P100x	Besteam Technology, Inc.	INI	Class II	2006-02-14
K053523	Powder Free Sterile Vinyl Glove (Clear and Yellow)	Shijiazhuang Hongxiang Plastics Products Co., Ltd.	LYZ	Class I	2006-02-14
K053387	Perioglas Bone Graft Particulate	Novabone Products, LLC	LYC	Class II	2006-02-14
K053099	Biohorizons Plastic Temporary Abutments	BioHorizons Implant Systems Inc	NHA	Class II	2006-02-14
K060203	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2006-02-13
K060194	March Healthcare Health Monitoring Kit	March Healthcare Corporation	DXN	Class II	2006-02-13
K060144	Seednet/seednetgold, Cryothera and Cryo-Hit Systems	Galil Medical Ltd.	GEH	Class II	2006-02-13
K060130	Immage Systems Low Concentration Immunoglobulin a Reagent	Siemens Healthcare Diagnostics Inc.	CZP	Class II	2006-02-13
K060081	Basis Spinal System	Medtronic Sofamor Danek	KWP	Class II	2006-02-13
K053657	Powder Free Nitrile Examination Gloves, Non-Sterile	Pt Mahakarya Inti Buana	LZA	Class I	2006-02-13
K053608	Cynosure Photogenica V-Star Laser	Cynosure, LLC	GEX	Class II	2006-02-13
K053508	Synfix-Lr	Synthes Spine Co.Lp	MQP	Class II	2006-02-13
K053316	Reprocessed Compression Sleeves	Alliance Medical Corp.	JOW	Class II	2006-02-13
K053070	Contour II Spinal System	Altiva Corp.	MNH	Class II	2006-02-13
K052966	Ci Knee, Ci Mi Tkr	Brainlab, Inc.	HAW	Class II	2006-02-13
K052965	Easytrak 2 Stylet, Models 4826, 4829, 4832.	Boston Scientific Corporation	DRB	Class II	2006-02-13
K052797	Lapevac, Filtration Device for the Periotoneum	Medtek Devices, Inc.	FYD	Class II	2006-02-13
K060211	Wuzhou Syringe, With/without Needle	Wenzhou Wuzhou Group Co., Ltd.	FMF	Class II	2006-02-10
K060210	Mediport	Maxant Technologies, Inc.	LLZ	Class II	2006-02-10
K060095	Modification to: Vaclok Syringe	Wrightmedicaltechnologyinc	FMF	Class II	2006-02-10
K053602	Procera Software, Model 33145	Nobel Biocare AB	NHA	Class II	2006-02-10
K053216	Hearid Wideband Middle Ear Power Analyzer	Mimosa Acoustics, Inc.	EWO	Class II	2006-02-10
K052983	Fluoroperm 151 (Paflufocon D) and Paragon Hds 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses	Paragon Vision Sciences, Inc.	HQD	Class II	2006-02-10
K052594	Willcare, Model Gw-1020	Abbott Medical	FRN	Class II	2006-02-10
K051961	Wwmed, Model 401	Wong Way Corporation	ILY	Class II	2006-02-10
K060220	Pbs Model 701A Compression Therapy Device	Mego Afek	JOW	Class II	2006-02-09
K060083	Nrbc-Chex for Lh	Streck LLC	GJR	Class II	2006-02-09
K053644	Thrombigel Thrombin/gelatin Foam Hemostat	Vascular Solutions LLC	QSX	Unclassified	2006-02-09
K053603	C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments	Roche Diagnostics GmbH	NQD	Class II	2006-02-09
K053127	Iplan	Brainlab, Inc.	HAW	Class II	2006-02-09
K053032	Acro Biotech Llc Rapid Amphetamine Urine Test; Catalog# Amp001000	ACRO BIOTECH Inc.	DKZ	Class II	2006-02-09
K052858	Soothies Gel Pads	Puronxy, Inc.	NXH	Class I	2006-02-09
K052591	Nanopia Wide Range C-Reactive Protein (Crp) Reagent Kit	Clinical Data, Inc.	DCK	Class II	2006-02-09
K060179	Bio-Ray Sdx Digital X-Ray System	Sigma Biomedics, Inc.	MUH	Class II	2006-02-08
K060080	Diagnodent 2190 with Periodontal Probe	KaVo Dental GmbH	NTK	Class II	2006-02-08
K060079	Kodak Model Cr-7400 Digital Radiography System	Eastman Kodak Company	MUH	Class II	2006-02-08
K053618	Inspectra Tissue Spectrometer System, Model 325	Hutchinson Technology, Inc.	MUD	Class II	2006-02-08
K053592	Simplant Dr. James	Materialise N.V.	LLZ	Class II	2006-02-08
K053429	Advanced Urological Catheter	Entracare Corp.	EZL	Class II	2006-02-08
K052499	Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays	Diasorin Inc.	LGD	Class II	2006-02-08
K052281	Embrace Wetbond Clear Sealant	Pulpdent Corporation	EBC	Class II	2006-02-08
K052125	Carbonaid Gas Diffuser	Cardia Innovation AB	HIF	Class II	2006-02-08
K050806	Optecure	Exactech, Inc.	MBP	Class II	2006-02-08