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 1282 of 3531

510(k) clearances, page 1282 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060176	El-Acl Screen; El-Acl Igm, Igg, Iga	Theratest Laboratories, Inc.	MID	Class II	2006-02-07
K060142	Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers	Vascutek, Ltd.	DSY	Class II	2006-02-07
K060084	Lysus Infusion System	Ekos Corp.	QEY	Class II	2006-02-07
K060055	Kodak Pacs	Eastman Kodak Company	LLZ	Class II	2006-02-07
K060041	Trimed Bone Plates	Trimed Inc	HRS	Class II	2006-02-07
K053576	Dimension Vista Myo Reagent Cartridge and Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2006-02-07
K053426	Roche Elecsys Anti-Tg	Roche Diagnostics GmbH	JZO	Class II	2006-02-07
K053058	Xltek Neuropath, Model Pk1070	Excel Tech., Ltd.	JXE	Class II	2006-02-07
K052793	Immunocap/unicap Gliadin Iga, Immunocap/unicap Specific Iga, Models 14-4425-40, 10-9306-02	Pharmacia Diagnostics, Inc.	MST	Class II	2006-02-07
K052439	Aeskulisa Glia a and Aeskulisa Glia G	Aesku Diagnostics	MST	Class II	2006-02-07
K060107	Modification to: Exactech Ziramic Zirconia 12/14 Femoral Heads	Exactech, Inc.	LZO	Class II	2006-02-06
K053627	Modification to: V.a.c. Granufoam Silver Protection Dressing	KCI USA, Inc.	OMP	Class II	2006-02-06
K053390	Columbus (Cr) Total Knee System	Aesculap Inc	JWH	Class II	2006-02-06
K053361	Modification to: Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	OTO	Class II	2006-02-06
K053094	Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056	Advanced Bio-Surfaces, Inc.	HSH	Class II	2006-02-06
K053061	Emit 2000 Cyclosporine Specific Assay	Siemens Healthcare Diagnostics Inc.	MKW	Class II	2006-02-06
K052162	Sheffield Brand Warming Lubrigel Personal Lubricant	Sheffield Laboratories, Div. of Faria Limited, LLC	NUC	Class II	2006-02-06
K051699	Sejoy, Model Mt-403	Sejoy Electronics & Instruments Co., Ltd.	FLL	Class II	2006-02-06
K060152	Modification to S4 Spinal System	Aesculap Inc	MNI	Class II	2006-02-03
K060149	Sunipan Imaging System & Accessories	Suni Medical Imaging, Inc.	MUH	Class II	2006-02-03
K060088	Microscan Synergies Plus Gram Positive Mic/combo Panels - Ampicillin	Siemens Healthcare Diagnostics Inc.	LON	Class II	2006-02-03
K060062	Straumann Orthosystem	Straumann USA, LLC	OAT	Class II	2006-02-03
K060060	Biograph 6	Siemens Medical Solutions USA, Inc.	KPS	Class II	2006-02-03
K053655	Tendon Wrap Tendon Protector	Integra LifeSciences Corporation	FTM	Class II	2006-02-03
K053565	Tempbond Clear with Triclosan	Sybron Dental Specialties, Inc.	EMA	Class II	2006-02-03
K053533	Immulite/immulite 1000 Turbo Intact Pth	Siemens Healthcare Diagnostics Inc.	CEW	Class II	2006-02-03
K053500	Frameless Radiosurgery Components	Brainlab, Inc.	IYE	Class II	2006-02-03
K053473	Maestro Mdtl Laser System	Advanced Medical Technologies AG	ILY	Class II	2006-02-03
K053461	Ezloc Femoral Fixation Device	Arthrotek, Inc.	MBI	Class II	2006-02-03
K053411	Dri Hemoglobin A1c Assay and Calibrators	Microgenics Corporation	LCP	Class II	2006-02-03
K053371	Ams Male Transobturator Sling System	American Medical Systems, Inc.	OTM	Class II	2006-02-03
K053301	Cedara I-Response Cedara Pet/ct	Cedara Software Corp.	LLZ	Class II	2006-02-03
K053240	Devilbiss Oxygen Cylinder Filling System, 535 Series	Sunrise Medical, Inc.	CAW	Class II	2006-02-03
K053205	Res Traxx Data Center	ResMed Corp	BZD	Class II	2006-02-03
K053204	Intellivue Gas Modules, Models G5 M1019a and G1 M1013a	Draeger Medical AG & Co. KGaA	CCK	Class II	2006-02-03
K053006	Rossmax Digital Sphygmomanometer Mandaus II	Rossmax Internationl, Ltd.	DXQ	Class II	2006-02-03
K052796	Cool-Tip RF Generator, Cool-Tip RF System Accessories	Medtronic, Inc.	GEI	Class II	2006-02-03
K052696	Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing	Covalon Technologies Inc.	FRO	Unclassified	2006-02-03
K052671	Hoca Ez-Care Bp108, Tender-Care Bp109	Hoca Medical Microsystem, Inc.	DXN	Class II	2006-02-03
K052546	Aegis Anterior Lumbar Plate System	DePuy Spine, Inc.	KWQ	Class II	2006-02-03
K051288	Vielle Lubricant	Cst Medical Limited	HIS	Class II	2006-02-03
K051217	Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin, E=pretin, E-Pp and E-Pt/e-P)	GE Healthcare	MHX	Class II	2006-02-03
K050668	Grt Lite, Model 8-a	Grt Solutions, Inc.	NHN	Class II	2006-02-03
K050516	T-Sling	Herniamesh SRL	OTN	Class II	2006-02-03
K043587	Sucralfate and Carafate Paste Kits	Patrick D. Mcgrath Ph.D	FRO	Unclassified	2006-02-03
K042114	Mdl Series Diode Lasers, Model Mdl-10/15	Vision Lasertechnik, GmbH	GEX	Class II	2006-02-03
DEN060008	Influenza A/h5 (Asian Lineage) Virus Real-Time Rt-PCR Primer and Probe Set	Centers for Disease Control and Prevention	NXD	Class II	2006-02-03
K060008	Aquadex Flexflow System	Chf Solutions, Inc.	KDI	Class II	2006-02-02
K052446	Lg1 Intelligent Medical Vigilance System	Hoana Medical, Inc.	DRT	Class II	2006-02-02
K052192	Femspce-S Disposable Sterile Vaginal Speculum, Model St-I	Femspec LLC	HIB	Class II	2006-02-02