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 540 of 3529

510(k) clearances, page 540 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173256	System 1 endo Liquid Chemical Sterilant Processing System	STERIS Corporation	MED	Class II	2018-03-02
K173223	ologen Collagen Matrix	Aeon Astron Europe B.V.	KGN	Unclassified	2018-03-02
K172972	Wrist Type Automatic Blood Pressure Monitor	Shenzhen Jiacom Technology CO., Ltd.	DXN	Class II	2018-03-02
K172601	Next Generation iBOT	Deka Research & Development Corp.	IMK	Class II	2018-03-02
K172590	Spectra Optia Apheresis System	Terumobct, Inc.	LKN	Unclassified	2018-03-02
K172485	Footmotion HammerToe	Newclip Technics	HTY	Class II	2018-03-02
K172331	Type I, Type II, Type III, Type IV	Lepu Medical Technology (Beijing) Co., Ltd	DYB	Class II	2018-03-02
K172256	SoftVue	Delphinus Medical Technologies, Inc.	IYO	Class II	2018-03-02
K172135	uCT Computed Tomography X-ray System	Shanghai United Imaging Healthcare Co., Ltd.	JAK	Class II	2018-03-02
K172103	Flowtron DVT5 Small Calf Garment	Arjo (Suzhou) Co., Ltd.	JOW	Class II	2018-03-02
K171655	cobas m 511 integrated hematology analyzer	Roche Diagnostics Hematology, Inc.	GKZ	Class II	2018-03-02
K171214	Infrared Thermometer	Shenzhen Brav Electronic Technologies Co., Ltd	FLL	Class II	2018-03-02
K171129	CO Check Pro, CO Screen	MD Diagnostics Ltd	CCJ	Class II	2018-03-02
K170304	Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers	Astell Scientific Limited	FLE	Class II	2018-03-02
K162366	Omega VL	Ov World Co., Ltd.	NEW	Class II	2018-03-02
K180109	STARband, STARlight, St. Louis Band	Orthomerica Products, Inc.	OAN	Class II	2018-03-01
K173806	CorPath GRX System	Corindus, Inc.	DXX	Class II	2018-03-01
K173788	Arthrex Corkscrew FT	Arthrex GmbH	MAI	Class II	2018-03-01
K173680	Sapphire II PRO	Orbusneich Medical Trading, Inc.	LOX	Class II	2018-03-01
K173488	CELERITY 20 HP Challenge Pack	STERIS Corporation	FRC	Class II	2018-03-01
K172916	FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603	FUJIFILM Corporation	FDS	Class II	2018-03-01
K172820	Microscope Navigation Software	Brainlab, Inc.	HAW	Class II	2018-03-01
K172500	Technoweb Surgical Mask	Yts Global, Inc.	FXX	Class II	2018-03-01
K171915	Nathanson Transcystic Bile Duct Stone Exploration Pack	Cook Incorporated	LQR	Class II	2018-03-01
K171703	PUMA System	Panther Orthopedics, Inc.	HTN	Class II	2018-03-01
DEN160029	SkinPen Precision System	Bellus Medical, LLC	QAI	Class II	2018-03-01
K180255	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup	Hangzhou Clongene Biotech Co., Ltd.	PTH	Class II	2018-02-28
K180244	EnsoETM	Advanced Cooling Therapy, Inc. D/B/A Attune Medical	PLA	Class II	2018-02-28
K180242	HeRO Symphony, HeRO ES, HeRO solo/duet	Medical Predictive Science Corp.	DPS	Class II	2018-02-28
K173817	Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL	Liofilchem S.r.l.	JWY	Class II	2018-02-28
K173763	iovera system	Myoscience, Inc.	GXH	Class II	2018-02-28
K173739	Aloka Arietta 850	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2018-02-28
K173736	TrackX	Track X Technology, LLC	OWB	Class II	2018-02-28
K173729	Revian Red	Photonmd, Inc.	OAP	Class II	2018-02-28
K173707	P200te	Optos PLC.	OBO	Class II	2018-02-28
K173691	Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack	Ortho-Clinical Diagnostics, Inc.	LSR	Class II	2018-02-28
K173678	Diode Laser Cap	Cosmo Far East Technology Limited	OAP	Class II	2018-02-28
K173633	VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag	STERIS Corporation	FRC	Class II	2018-02-28
K173367	MC 300* Nebulizer	Trudell Medical International	CAF	Class II	2018-02-28
K173186	S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D	Everyway Medical Instruments Co., Ltd.	GXY	Class II	2018-02-28
K173145	CereMetrix Silver	Ceremetrix Corp	LLZ	Class II	2018-02-28
K172868	Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls	The Binding Site Group Ltd.	DCN	Class II	2018-02-28
K172797	ECG Cable/Leadwires	Shenzhen Coreray Technology Co., Ltd.	DSA	Class II	2018-02-28
K172750	Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)	Guangzhou Sonostar Technologies Co., Ltd.	IYO	Class II	2018-02-28
K180237	Rezum System	Nxthera, Inc.	KNS	Class II	2018-02-27
K173746	Activmotion Range	Newclip Technics	HRS	Class II	2018-02-27
K173683	LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers	Diasorin Inc.	PRI	Class II	2018-02-27
K173343	Zygomatic Implant System	Southern Implants, (Pty.) Ltd.	DZE	Class II	2018-02-27
K173324	ALTA Anterior Cervical Interbody Spacer	Astura Medical	ODP	Class II	2018-02-27
K173275	Omnichroma	Tokuyama Dental Corporation	EBF	Class II	2018-02-27