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 517 of 3529

510(k) clearances, page 517 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171550	Sterile Latex Surgical Gloves, Powder Free	Sanrea Healthcare Products Pvt Ltd	KGO	Class I	2018-07-13
K181287	Catalyst CSR Shoulder System	CATALYST ORTHOSCIENCE Inc	KWT	Class II	2018-07-12
K181276	CONOD Enteral Feeding Sets	Conod Medical Co., Ltd.	PIF	Class II	2018-07-12
K181043	StatStrip Glucose Hospital Meter System	Nova Biomedical Corporation	PZI	Class II	2018-07-12
K181011	Aim2	GC America Inc.	ELW	Class II	2018-07-12
K180695	Fbc 921 (Alif)	Fbc Device ApS	OVD	Class II	2018-07-12
K180613	Estelite Universal Flow	Tokuyama Dental Corporation	EBF	Class II	2018-07-12
K180575	THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X	Olympus Medical Systems Corp.	GEI	Class II	2018-07-12
K180552	Modified Novy Cornual Cannulation Set	Cook Incorporated	MOV	Class II	2018-07-12
K173627	Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector	Medline ReNewal	NLQ	Unclassified	2018-07-12
K173511	ActiveCare TD-4121 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2018-07-12
K173206	SEKURE HbA1c Assay	Sekisui Diagnostics P.E.I. Inc.	PDJ	Class II	2018-07-12
K172874	Infrared Thermometer	Shenzhen Jiacom Technology CO., Ltd.	FLL	Class II	2018-07-12
K171274	ADVIA Centaur High-Sensitivity Troponin I (TNIH)	Siemens Healthcare Diagnostics Inc.	MMI	Class II	2018-07-12
K181697	16ch Foot/ Ankle SPEEDER	Quality Electrodynamics	MOS	Class II	2018-07-11
K181523	Syneron CO2RE System	Syneron Candela Corporation	GEX	Class II	2018-07-11
K180967	Dental Diode Laser System	Lazon Medical Laser Co., Ltd.	GEX	Class II	2018-07-11
K180963	Roccia Alif, Roccia Tlif	Silony Medical GmbH	MAX	Class II	2018-07-11
K180816	Ziehm RFD 3D Tracker	Medtronic Navigation, Inc	OLO	Class II	2018-07-11
K180730	INVISION Total Ankle Revision System	Wrightmedicaltechnologyinc	HSN	Class II	2018-07-11
K180725	Aspire Introducer Needle	Aspire Bariatrics, Inc.	KNT	Class II	2018-07-11
K180314	Infrared Thermometer	Xuzhou Yongkang Electronic Science Technology Co., Ltd	FLL	Class II	2018-07-11
K180024	SALVATION Midfoot Nail	Wrightmedicaltechnologyinc	HWC	Class II	2018-07-11
K173969	Medicalgorithmics Unified Cardiac Rehabilitation System	Medicalgorithmics S.A.	DSI	Class II	2018-07-11
K173881	Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G	Owen Mumford Limited	FMI	Class II	2018-07-11
K173801	Transcranial Doppler Ultrasound System	Shenzhen Delica Medical Equipment Co., Ltd.	IYN	Class II	2018-07-11
K173631	Intelli-C	NRT X-Ray a/S	OWB	Class II	2018-07-11
K173486	NTU-USB Ultrasound USB Box	National Taiwan University	IYN	Class II	2018-07-11
K172543	High-speed Turbine Handpieces for Single Use	Beijing Dongbo Dental Handpiece Co., Ltd.	EFB	Class I	2018-07-11
K181700	HardyDisk AST Plazomicin 30ug (PLZ30)	Hardy Diagnostics	JTN	Class II	2018-07-10
K181574	Uscan	Echonous Inc	IYO	Class II	2018-07-10
K181572	Workflow Box	Mirada Medical Limited	QKB	Class II	2018-07-10
K181246	Zavation IBF System	Zavation Medical Products, LLC	MAX	Class II	2018-07-10
K181244	Zavation Cervical Plate System	Zavation Medical Products, LLC	KWQ	Class II	2018-07-10
K181201	Synermed ISE Reagents	Infrared Laboratory Systems, LLC (dba Synermed)	JGS	Class II	2018-07-10
K180970	Disposable guides KDNG00	Koelis	ITX	Class II	2018-07-10
K180900	LED Light Therapy Device	Uvbiotek, LLC	OLP	Class II	2018-07-10
K180697	Pseudo-Patient	Rtsafe, Inc.	IYE	Class II	2018-07-10
K180289	3D Bolus Software	3D Bolus, Inc.	MUJ	Class II	2018-07-10
K173274	Ceevra Reveal 2.0	Ceevra, Inc.	LLZ	Class II	2018-07-10
K173039	TruMatch CMF Titanium 3D Printed Implant	Materialise N.V.	JEY	Class II	2018-07-10
K172991	Advanced Dental Applicance	Dasoft Partners	LRK	Class II	2018-07-10
K181547	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)	Echosens	IYO	Class II	2018-07-09
K181522	PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope	PENTAX of America, Inc.	FDT	Class II	2018-07-09
K181261	Curiteva Cervical Interbody Fusion System	Curiteva, Inc.	ODP	Class II	2018-07-09
K180930	Empowr Vvc Tibial Insert	Encore Medical, LP	JWH	Class II	2018-07-09
K180923	Personal Lubricating Jelly	Perrigo New York, Inc.	NUC	Class II	2018-07-09
K180798	Prime Acetabular Cup System	Microport Orthopedics Inc.	LPH	Class II	2018-07-09
K173562	Straumann Jason Membrane	Straumann USA, LLC	NPL	Class II	2018-07-09
K173766	PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs	Shen Wei (USA), Inc.	LZC	Class I	2018-07-08