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 1434 of 3531

510(k) clearances, page 1434 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033151	Kfa-12 Knee, Foot, and Ankle Array Coil	Mri Devices Corp.	MOS	Class II	2003-10-10
K033073	Orthophos Xg Ds/ceph	Sirona Dental Systems GmbH	EHD	Class II	2003-10-10
K033043	Modification to Hl168	Health & Life Corporation	DXN	Class II	2003-10-10
K033010	Brm2 Brain Monitor	Brainz Instruments, Ltd.	OLT	Class II	2003-10-10
K032956	Accusonic a-Scan Model, 24-4000	Accutome, Inc.	IYO	Class II	2003-10-10
K032924	Radiodexter Version 1.0, Dextroscope, Model Mk10 and Dextrobeam, Model Mk3	Volume Interactions Pte, Ltd.	LLZ	Class II	2003-10-10
K032881	Immulite/immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	2003-10-10
K032858	The Philips Intellivue Mp40, Mp50, Mp60, Mp70,and Mp90 Patient Monitors, Release B.o.	Philips Medizin Systeme Boblingen GmbH	DSI	Class II	2003-10-10
K032839	Hl888ba	Health & Life Corporation	DXN	Class II	2003-10-10
K032837	Hl888bm	Health & Life Corporation	DXN	Class II	2003-10-10
K032620	Ge Voluson 730 Pro/expert Bt03 Ultrasound System	General Electric Co.	IYN	Class II	2003-10-10
K032577	Modification to: Mac-Lab/cardiolab Ep/combolab System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2003-10-10
K032471	Tytron C-500Ir Clinical Infrared Imaging System	Titronics Research & Development	LHQ	Class I	2003-10-10
K032467	Maxter Sterile Powdered Latex Surgical Gloves	Maxter Glove Manufacturing Sdn Bhd	KGO	Class I	2003-10-10
K032413	Kls-Martin Sternal Plating System	KLS-Martin L.P.	HRS	Class II	2003-10-10
K032310	Mini V.a.c., V.a.c. Freedom, V.a.c. Ats	KCI USA, Inc.	OMP	Class II	2003-10-10
K032290	Fukuda Denshi Dynascope Model Ds-7100 Series Portable Patient Monitor	Fukuda Denshi USA, Inc.	MHX	Class II	2003-10-10
K032279	Online Tdm Amika	Roche Diagnostics GmbH	KLP	Class II	2003-10-10
K032201	Rubbercare Powdered Latex Examination Gloves	Perusahaan Pelindung Getah (M) Sdn Bhd	LYY	Class I	2003-10-10
K032115	Neurolac Nerve Guide Models Ng01-15/03, Ng01-020/03, Ng01 025/03, Ng01-030/03	Polyganics B.V.	JXI	Class II	2003-10-10
K032071	Powder Free Vinyl Examination Glove	Shanghai Foremost Plastic Industrial Co., Ltd.	LYZ	Class I	2003-10-10
K031901	Proven Revision Femoral and Proven Revision Tibial Insert	Globus Medical, Inc.	JWH	Class II	2003-10-10
K031863	Carestation 126S Videophone	Motion Media Technology, Inc.	MWI	Class II	2003-10-10
K031840	Carematix Wellness System	Carematix Inc.	DXN	Class II	2003-10-10
K031797	Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. No. 190 (500 Test Kit), No. 191 (5000 Test Kit)	Lin-Zhi International Inc	DJR	Class II	2003-10-10
K031760	Viewpoint Telemetry System	Datascope Corp.	MHX	Class II	2003-10-10
K031607	Orion Diagnostica Quikread Crp Kit and Quikread Crp Control	Orion Diagnostica, Div. Orion Corp.	DCK	Class II	2003-10-10
K031471	Oria Spinal Clip System, Lateral Intermediate Connector, Model Al01	Ortho Tec, LLC	KWP	Class II	2003-10-10
K031465	Model 2100 Pulse Oximeter	Dolphin Medical, Inc.	DQA	Class II	2003-10-10
K031195	Cuf-Cover (Tm)	Ethox Corp.	DXQ	Class II	2003-10-10
K030998	Medrelief Se Series, Models Se-50, Se-100, Se-200, Se-300	Healthonics, Inc.	IPF	Class II	2003-10-10
K030910	Clued Up Multipurpose Solution- No Rub	Clued UP Limited	LPN	Class II	2003-10-10
K030737	Omega Whole-Cortex Mfg System, Models Omega 151, Omega 275	Ctf Systems (2001), Inc.	OLX	Class II	2003-10-10
K030539	Lasersmile	Biolase MG LLC	GEX	Class II	2003-10-10
K023209	Insight Millennium III	Fasstech	IKN	Class II	2003-10-10
K033160	Synthes Sterile Low Profile Neuro Contourable Mesh Plates	Synthes (USA) Products LLC	JEY	Class II	2003-10-09
K032898	T2 Recon Nail System	Howmedica Osteonics Corp	HSB	Class II	2003-10-09
K032854	Unomedical Monica Infusion Set	Unomedical A/S	FPA	Class II	2003-10-09
K032826	Mas Par Tdm	Medical Analysis Systems, Inc.	DIF	Class I	2003-10-09
K032793	US-100 Portable Ultrasound Therapy Unit	Ito Co., Ltd.	IMI	Class II	2003-10-09
K032789	Replacement Pump Head Door Assembly, P1, Model Bx10468, Replacement Pump Head Door Assembly, P2, Model Bx10469	American I.V. Products, Inc.	FRN	Class II	2003-10-09
K032768	Medtronic, Inc. Racer Biliary Stent System (Racer), Model Xd#yf(l)	Medtronic, Inc.	FGE	Class II	2003-10-09
K032724	Pinnacle3 Radiation Therapy Planning System	Philips North America LLC	MUJ	Class II	2003-10-09
K032700	Blackstone Surgical Titanium Mesh System Angled End Rings	Blackstone Medical, Inc.	MQP	Class II	2003-10-09
K032654	Port Cassette	Orex Computed Radiography, Ltd.	IXK	Class II	2003-10-09
K032581	Global Modular Replacement System Anteverted Promimal Femoral Component	Howmedica Osteonics Corp	LPH	Class II	2003-10-09
K032506	Sanarus Centrica II Rotational Core Biopsy System	Sanarus Medical, Inc.	KNW	Class II	2003-10-09
K032427	Fep Fixation System and Stylo Wrist Fixation System	Meridan Medical	JEC	Class II	2003-10-09
K032368	Sonoma Anterior Cervical Plate System	Seaspine, Inc.	KWQ	Class II	2003-10-09
K032357	Novus Ttx Laser and Delivery Devices with Accessories	Lumenis Ltd	GEX	Class II	2003-10-09