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 1436 of 3531

510(k) clearances, page 1436 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032702	Vivatip Microwave Ablation Probe	Vivant Medical, Inc.	GEI	Class II	2003-10-03
K032630	Disposable Powder Free Vinyl Exam Gloves	Kingswell International, Inc.	LYZ	Class I	2003-10-03
K032461	Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221	Lin-Zhi International Inc	DIC	Class II	2003-10-03
K032349	Placer	Abbott Medical	GZB	Class II	2003-10-03
K032231	Medx1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser	Medx Electronics, Inc.	ILY	Class II	2003-10-03
K032200	Elan Digital 12 Channel Electrocardiograph	Remco Italia S.p.A.	DPS	Class II	2003-10-03
K032085	Green Laser Photocoagulator Model Gyc-1000	Nidek, Inc.	GEX	Class II	2003-10-03
K032066	Sonosurg System	Olympus Optical Co., Ltd.	LFL	Unclassified	2003-10-03
K032055	Meds-4-Inf+	Medical Equipment Device Specialists	GZJ	Class II	2003-10-03
K032034	Ans Axxess Percutaneous Lead	Abbott Medical	GZB	Class II	2003-10-03
K030923	Epsilon Durasul Constrained Acetabular Liner	Centerpulse Orthopedics, Inc.	KWZ	Class II	2003-10-03
K030279	Reprocessed Electrophysiology Catheter	Alliance Medical Corp.	NLH	Class II	2003-10-03
K032913	Hl888 Af	Health & Life Corporation	DXN	Class II	2003-10-02
K032889	Optical Separator	Applied Medical Resources Corp	GCJ	Class II	2003-10-02
K032790	Micromlc	Siemens Medical Solutions USA, Inc.	IXI	Class II	2003-10-02
K032750	Modification to: Xive 3.0 Dental Implant System, Multiple	Friandent GmbH	DZE	Class II	2003-10-02
K032737	Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta	Cordis Europa, N.V.	DQY	Class II	2003-10-02
K032712	Vaxcel Plus Chronic Dialysis Catheter	Boston Scientific Corporation	MSD	Class II	2003-10-02
K032695	Hl888bf	Health & Life Corporation	DXN	Class II	2003-10-02
K032673	Immix Plastifilm	Osteobiologics, Inc.	FTL	Class II	2003-10-02
K032616	Disposable Powder Free Vinyl Synthetic Exam Gloves	Elite International, Inc.	LYZ	Class I	2003-10-02
K032587	Edwards Peripheral Dilatation Catheter	Edwards Lifesciences LLC	DQY	Class II	2003-10-02
K032344	The Hedrocel Trabecular Metal Reconstruction System Model 10-330	Implex Corp.	EZX	Class II	2003-10-02
K032324	Echoencoder	Icardiogram, Incorporated	LLZ	Class II	2003-10-02
K032302	Xive Tg Abutments	Friadent GmbH	DZE	Class II	2003-10-02
K032243	Minicat Dentocat	Xoran Technologies, LLC	JAK	Class II	2003-10-02
K032234	Mk-Dent High Speed Dental Handpiece, Models Hs 4021K, 4011K, 4012K, and Hs 6021K, 6011K, 6012K	MK-dent GmbH	EFB	Class I	2003-10-02
K032210	Alara Crystalview Computed Radiography System	Alara, Inc.	MQB	Class II	2003-10-02
K032177	Gastrointestinal Videoscope Xgif-Q14om, Xgif-2T140m Colonovideoscope Xcf-Q14ml/i, Xpcf-160Aml/i	Olympus Opto-Electronics Co., Ltd.	FDS	Class II	2003-10-02
K032140	5.0 X 5Mm Endopore Endosseous Dental Implant System	Innova Life Sciences Corp.	DZE	Class II	2003-10-02
K032100	I-Beam	Elekta Limited	IYE	Class II	2003-10-02
K032079	Hls Noetos System	TORNIER Inc.	JWH	Class II	2003-10-02
K032004	Aquaboss Ecoro Dia 50	Lauer Ltd., Hong Kong	FIP	Class II	2003-10-02
K031590	Sectra Orthopedic Package	Sectra-Imtec AB	LLZ	Class II	2003-10-02
K031567	3D Invivo by Csist	Chung-Shan Institute of Science and Technology	LLZ	Class II	2003-10-02
K031439	Alginate Impression Material III (Fast & Regular)	Harry J. Bosworth Co.	ELW	Class II	2003-10-02
K032805	Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit	Vascular Solutions LLC	GEX	Class II	2003-10-01
K032723	Biosign Steam-24 Biological Indicator	Getinge USA, Inc.	FRC	Class II	2003-10-01
K032722	Trigen Straight Humeral Nail System	Smith & Nephew, Inc.	HSB	Class II	2003-10-01
K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	LXT	Class II	2003-10-01
K032320	Appollo 3 Alloy	Dentsply International, Inc.	EJT	Class II	2003-10-01
K032144	Perifix Catheter Connector	B.Braun Medical, Inc.	CAZ	Class II	2003-10-01
K032072	Lactosorb L15 Screw Anchor with Lactocarbonate Suture	Arthrotek, Inc.	HWC	Class II	2003-10-01
K032023	W.o.m. Laser U100plus	Novanta Medical GmbH	GEX	Class II	2003-10-01
K031922	Captiva Blood Containment Device Cn100, Can19t71w	Merit Medical Systems, Inc.	DYB	Class II	2003-10-01
K031523	Olympus Ultrasonic Surgical System	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LFL	Unclassified	2003-10-01
K031440	Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser	Cynosure, LLC	GEX	Class II	2003-10-01
K031389	Cynosure Smart 2940D Er:yag Laser	Cynosure, LLC	GEX	Class II	2003-10-01
K024133	Cls-2000 Unit	Dentsply Intl.	FLE	Class II	2003-10-01
K024023	Essex High Pressure (Hp) Ocd and Essex Escort Pneumatic Conserver	Essex Medical Systems Plus	NFB	Class II	2003-10-01