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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 538 of 3529

510(k) clearances, page 538 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173203	Athena GTX Device Management Suite (ADMS) Software	Athena GTX	MSX	Class II	2018-03-14
K172795	Infrared Thermometer	Shenzhen Jumper Medical Equipment Co.,Ltd.	FLL	Class II	2018-03-14
K172431	Cardiovascular Analzyer	Physiowave, Inc.	DSB	Class II	2018-03-14
K172266	Dynarex Three-Way Stopcock	Dynarex Corp.	FMG	Class II	2018-03-14
K172012	star RF Electrode, VIVA RF Electrode	Starmed Co.,Ltd	GEI	Class II	2018-03-14
K171778	MR Wireless Gating System, Model WGS-100	Ivy Biomedical Systems, Inc.	LNH	Class II	2018-03-14
K180374	Voluson S8/ Voluson S10/ Voluson S10 Expert	GE Healthcare	IYN	Class II	2018-03-13
K180106	ThinkQA	Dosisoft	IYE	Class II	2018-03-13
K173792	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay	Phadia AB	MOB	Class II	2018-03-13
K173785	Custom Clear Aligner System	Derby Dental Laboratory	NXC	Class II	2018-03-13
K173694	STERIZONE VP4 Sterilizer	Tso3, Inc.	PJJ	Class II	2018-03-13
K173459	Olympus Small Intestinal Capsule Endoscope System	Olympus Medical Systems Corp.	NEZ	Class II	2018-03-13
K171817	Biodesign Diaphragmatic Hernia Graft	Cook Biotech Incorporated	FTM	Class II	2018-03-13
K180450	Corvocet Biopsy System	Merit Medical Systems, Inc.	KNW	Class II	2018-03-12
K180262	SICAT Endo	Sicat GmbH & Co. KG	LLZ	Class II	2018-03-12
K173779	Rexmono, Pdrex	Sm Eng Co., Ltd.	GAM	Class II	2018-03-12
K173734	RocaJJ Soft Stents	Promepla S.A.M	FAD	Class II	2018-03-12
K173583	Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners	Exactech, Inc.	OQI	Class II	2018-03-12
K173229	Preview Digital Pregnancy Test	Guangzhou Wondfo Biotech Co., Ltd.	LCX	Class II	2018-03-12
K173628	Acclarent ENT Navigation System	Acclarent Inc	PGW	Class II	2018-03-10
K180394	BrightMatter Plan 1.6.0	Synaptive Medical Inc	LLZ	Class II	2018-03-09
K180159	Klassic® Knee System	Total Joint Orthopedics, Inc.	JWH	Class II	2018-03-09
K180061	UltraCor Twirl Breast Tissue Marker	Bard Peripheral Vascular Inc	NEU	Class II	2018-03-09
K180057	Vortek Ureteral Double Loop Stent	MEDLINE INDUSTRIES, LP - Northfield	FAD	Class II	2018-03-09
K173939	Quantib Brain	Quantib B.V.	LLZ	Class II	2018-03-09
K173904	CATS Tonometer Prism	Cats Tonometer, LLC	HKY	Class II	2018-03-09
K173812	Catalyst CSR 3 Peg Glenoids	CATALYST ORTHOSCIENCE Inc	KWT	Class II	2018-03-09
K173796	Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)	Sofradim Production	FTL	Class II	2018-03-09
K173690	Grass TWin	Natus Medical Incorporated	OLV	Class II	2018-03-09
K173682	L300 Go System	Bioness, Inc.	GZI	Class II	2018-03-09
K173481	Amsco Evolution Medium Steam Sterilizer	STERIS Corporation	FLE	Class II	2018-03-09
K173426	PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System	KCI USA, Inc.	OMP	Class II	2018-03-09
K173388	Exactech Equinoxe Stemless Shoulder	Exactech, Inc.	PKC	Class II	2018-03-09
K173078	Powder-free Clear Vinyl Patient Examination Gloves	Yongsheng Medical Products Co., Ltd.	LYZ	Class I	2018-03-09
K172799	Positional Sleep Assessment System (PoSAS) software	Advanced Brain Monitoring, Inc.	MNR	Class II	2018-03-09
K172057	Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set	Cook Ireland Ltd.	FGE	Class II	2018-03-09
K171820	Transjugular Liver Access Sets	Cook Incorporated	DYB	Class II	2018-03-09
K171764	Fixed Core Wire Guides	Cook Incorporated	DQX	Class II	2018-03-09
K162616	Wrist Type Blood Pressure Monitor	Xuzhou Yongkang Electronic Science Technology Co., Ltd	DXN	Class II	2018-03-09
K180335	Accutension Smartphone Auscultatory Blood	Shanghai Hulu Devices Co., Ltd.	DXQ	Class II	2018-03-08
K180326	icobrain	icometrix	LLZ	Class II	2018-03-08
K180171	PillCam Patency System	Given Imaging Ltd.	NSI	Class II	2018-03-08
K180135	THD Anopress with THD SensyProbe	Thd SpA	KLA	Class II	2018-03-08
K180105	Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister	Penumbra Inc.	QEW	Class II	2018-03-08
K180092	Intellitorq	Gauthier Biomedical, Inc.	HXC	Class I	2018-03-08
K180086	Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter	Gyrus ACMI, Inc.	FGE	Class II	2018-03-08
K180044	SIROLaser Blue	Dentsply Sirona Inc	GEX	Class II	2018-03-08
K173777	BreathID Hp Lab System	Meridian Bioscience Israel Ltd.	MSQ	Class I	2018-03-08
K173772	BreathID Hp System	Meridian Bioscience Israel Ltd.	MSQ	Class I	2018-03-08
K173769	DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid	DMAX Co., Ltd.	EIH	Class II	2018-03-08