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 1991 of 3531

510(k) clearances, page 1991 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953452	Ketorex C Sanwa	Ihara Medics U.S., Inc.	JMK	Class I	1996-05-02
K934695	Natural-Knee Tibial Baseplate/all Poly Patella	Intermedics Orthopedics	JWH	Class II	1996-05-02
K961372	Serum Tox Calibrator	Diagnostic Reagents, Inc.	DKB	Class II	1996-05-01
K960757	Karl Storz Ureter Resectoscope	Karl Storz Endoscopy-America, Inc.	FJL	Class II	1996-05-01
K960733	Ministick Pregnancy Test	Vanguard Biomedical Corp.	LCX	Class II	1996-05-01
K960519	Martech Endoscopic Injection Needle	Martech Medical Products	FBK	Class II	1996-05-01
K960080	Accutemp Probe	Kentec Medical, LLC	FMT	Class II	1996-05-01
K955382	3M Model 1860 Health Care Particulate Respirator Type N95	3M Company	FXX	Class II	1996-05-01
K961441	Tonometered Slaine Blood Gas Control	Instrumentarium Corp.	JJS	Class I	1996-04-30
K961185	Daum Biopsyneedle	Ferguson Medical	FCG	Class II	1996-04-30
K961135	Input 10F/11/f Introducer Set(010101(10f), 011101(11F)	C.R. Bard Inc	DYB	Class II	1996-04-30
K961074	Lightsource or Illuminator	Cuda Products Co.	FSS	Class II	1996-04-30
K960825	Lm Anchor or Other Proprietary Name	Li Medical Technologies, Inc.	MBI	Class II	1996-04-30
K960695	Model 200C Electrosurgical Probe	Zomed Intl.	GEI	Class II	1996-04-30
K960694	Zomed 30F Electrosurgical Probe	Zomed Intl.	GEI	Class II	1996-04-30
K960613	Ge Advantage Windows Review Workstation	GE Healthcare	LLZ	Class II	1996-04-30
K960581	Secure Eva Dual Chamber Mixing Bag	Secure Medical Products, Inc.	KPE	Class II	1996-04-30
K960001	Minimed Infusion Pump, Model Mmt-507	Medtronic, Inc.	LZG	Class II	1996-04-30
K955397	Mayfield-Acciss Workstation	Nomos Corp.	HAW	Class II	1996-04-30
K955247	Olympus Kd Series Sphincterotome	OLYMPUS Corporation of the Americas	KNS	Class II	1996-04-30
K954570	Ortho Immunocount Flow Cytometry System	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1996-04-30
K954506	Emox	Medtrak Intl., Inc.	CAW	Class II	1996-04-30
K954171	Arco-Mbc, Arco Mc	Holl Meditronics, Inc.	GEI	Class II	1996-04-30
K954158	Stc Diagnostics Auto-Lyte Ph Assay	Solarcare Technologies Corp,Inc.	KQO	Class I	1996-04-30
K953300	V-Cath Dual Lumen E.s.p. Peripheral Inserted Central Catheter	Hdc Corp.	LJS	Class II	1996-04-30
K952631	Braun Hemodialysis Blood Circuits	B.Braun Medical, Inc.	FJK	Class II	1996-04-30
K950646	Integrator	Moyco Union Broach, Div., Moyco Technologies, Inc.	LXM	Unclassified	1996-04-30
K961131	Salicylate Assay	Diagnostic Reagents, Inc.	DKJ	Class II	1996-04-29
K960923	Carbomedics Mitral Rotator	Carbomedics, Inc.	MOP	Class I	1996-04-29
K960880	Mill-Rose Blind Microbiology Brush	Mill-Rose Laboratory	EOQ	Class II	1996-04-29
K960815	Dupad, Dupad W/abdom. Pad, Dumex Abdom. Pad, Combo Dressing Roll/combine Dressing Roll	Dumex Medical Surgical Products, Ltd.	NAD	Class I	1996-04-29
K960657	Scimed Choice Pt Exchange Extra Support Ptca and Long Taper Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1996-04-29
K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires	Scimed Life Systems, Inc.	DQX	Class II	1996-04-29
K960381	Mam-Ch22s with Automatic Filter Selection Option	Elscint, Inc.	IZH	Class II	1996-04-29
K960316	Clearblue Easy	Unipath, Ltd.	LCX	Class II	1996-04-29
K960040	Sharplan Ultra Laparoscopic Handpiece	Sharplan Lasers, Inc.	LFL	Unclassified	1996-04-29
K955093	Aspiration/coagulation Electrode Ace-311 & Ace-511	Utah Medical Products, Inc	HGI	Class II	1996-04-29
K954903	Pedi Vaginal Aspirator	Cook Incorporated	HFC	Class II	1996-04-29
K954622	Ivt 0.014 Track or Ivt 0.014 Accutrack	Boston Scientific /International Technologies	DQX	Class II	1996-04-29
K954552	Railwire	Boston Scientific /International Technologies	DQX	Class II	1996-04-29
K951549	Ebna Igg Eia Test System	Immunoprobe, Inc.	LLM	Class I	1996-04-29
K943145	American, Economy Classic Sunglasses and Logo Lens Contra Vision Sunglasse	The Monticello Group, Inc.	HQY	Class I	1996-04-29
K961192	Irrigation System	Linvatec Corporation	ERL	Class II	1996-04-26
K961161	Avl Opti 1 Ph/blood Gas Analyzer	Avl Scientific Corp.	CHL	Class II	1996-04-26
K961148	Cefepime Dispans-O-Disc (Cefeplime - 30Mcg)	Difco Laboratories, Inc.	JTW	Class I	1996-04-26
K961076	Mm 324	Micro-Mega Societe Anonyme	EFB	Class I	1996-04-26
K960885	Model 1240, Small E Net	Physiometrix, Inc.	GXY	Class II	1996-04-26
K960873	Model 1210, Medium E-Net	Physiometrix, Inc.	GXY	Class II	1996-04-26
K960823	Prime & Bond 2.0 Multipurpose Dentin/enamel Bonding Agent	Dentsply Intl.	KLE	Class II	1996-04-26
K960729	Enamel Conditioner (Enamel Etching Agent)	Dent Zar, Inc.	EBF	Class II	1996-04-26