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 1766 of 3531

510(k) clearances, page 1766 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K983983	Edi Veris System	Electro-Diagnostic Imaging, Inc.	HLX	Class II	1999-02-03
K983950	Ceralas Diode Laser System (Model H)	Ceram Optec, Inc.	GEX	Class II	1999-02-03
K983925	Endopath Ultra Veress Needle	Ethicon Endo-Surgery Inc	HIF	Class II	1999-02-03
K983509	Inter-Op Acetabular System - Durasul Acetabular Insert	Sulzer Orthopedics, Inc.	LPH	Class II	1999-02-03
K983506	Pressurewire Sensor, Model #12001	Radi Medical Systems AB	DQX	Class II	1999-02-03
K982298	Opticoat T4 Eia Kit	Biotecx Laboratories, Inc.	KLI	Class II	1999-02-03
K981949	Numobag	Numotech, Inc.	KPJ	Class II	1999-02-03
K990266	Micromedical 12 Lead Simultaneous Cable	Micromedical Industries, Ltd.	LOS		1999-02-02
K990213	Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set	Gyrus Ent LLC	EOB	Class II	1999-02-02
K990055	B-400 Ceiling Mounted Possitioner, Model B-400	Omega Medical Imaging, LLC	JAA	Class II	1999-02-02
K984625	Architect Folate Masterchek, Model # 6C12-05	Bio-Rad	JJX	Class I	1999-02-02
K984604	Architect Estradiol Masterchek, Model # 6C22-05	Bio-Rad	JJX	Class I	1999-02-02
K984594	Lyphochek Maternal Serum Control, Model 220	Bio-Rad	JJY	Class I	1999-02-02
K984437	Quantex Aso-Crp-Rp Control II	Instrumentation Laboratory Co.	JJT	Class I	1999-02-02
K984419	Elecsys Ige Calcheck	Boehringer Mannheim Corp.	JJY	Class I	1999-02-02
K984406	Xiscan Office Expert Imaging System, Xiscan Surgical Expert Imaging System	Xitec, Inc.	OXO	Class II	1999-02-02
K984263	Ewc: ECG II Cable Leadwire System	Ewc	DSA	Class II	1999-02-02
K984228	Is Anti-Tpo Igg Elisa Test System	Columbia Bioscience, Inc.	JZO	Class II	1999-02-02
K984224	Perfusion Package for Magnetom Vision and Symphony Systems	Siemens Corp.	LNH	Class II	1999-02-02
K984186	Nichols Advantage Chemiluminescence Ferritin Immunoassay	Nichols Institute Diagnostics	DBF	Class II	1999-02-02
K984165	Anti-Thyroglobulin Eia Diagnostic Test Kit	The Binding Site	JZO	Class II	1999-02-02
K984163	Anti-Tpo Eia Diagnostic Test Kit	The Binding Site	JZO	Class II	1999-02-02
K983690	Vitros Immunodiagnostic Products Ca 15-3 Calibrators,vitros Immunodiagnostic Products Ca 15-3 Reagent Pack	Ortho-Clinical Diagnostics, Inc.	MOI	Class II	1999-02-02
K983457	Osteomark Ntx Serum Eia	Ostex Intl., Inc.	JMM	Class I	1999-02-02
K982731	Merogel Nasal Dressing and Sinus Stent	Xomed, Inc.	EMX	Class I	1999-02-02
K982307	Wallac Neonatal Leucine Test Kit Model Nl-1000	Wallac Oy	JNB	Class II	1999-02-02
K981725	Optovent Respiratory Monitor Model Number Rr 9700	Optovent AB	BZQ	Class II	1999-02-02
K980631	Embol-X Aortic Occlusion and Cardioplegia Cannula	Embol-X, Inc.	DXC	Class II	1999-02-02
K990158	Osteonics Combination Screw Ring/blocker	Osteonics Corp.	MNI	Class II	1999-02-01
K990120	Modification of Depuy Ace Timax Medial Pilon Plate	Depuy Ace Medical Co.	HSB	Class II	1999-02-01
K990095	Straight-in-Orthopedic Bone Screw Fixation System	Influence, Inc.	MBI	Class II	1999-02-01
K984488	Sheer Thin	Twe Companies, Inc.	HIS	Class II	1999-02-01
K984305	Zeta Multizone Locking Nail System	Howmedica Corp.	HSB	Class II	1999-02-01
K984291	Continuum Knee System Cobalt Chromium Alloy Tibial Component	Implex Corp.	JWH	Class II	1999-02-01
K984275	The Golden Tip Electro-Surgical Probe	Amada Surgical	GEI	Class II	1999-02-01
K984233	C.a.t.s Autotransfusion Accessories, Models Ats Suction Line, Aty Y-Adapter, and Ato Oxygenator Line	Fresenius Hemotechnology, Inc.	CAC	Class II	1999-02-01
K984183	Perma-Pass Vascular Graft, 5T Graft,model 31451	Possis Medical, Inc.	DYF	Class II	1999-02-01
K984182	Perma-Pass Vascular Graft, 6S Graft,model 31453, 6T Graft,model 31452	Possis Medical, Inc.	DSY	Class II	1999-02-01
K984124	Aesculap Xenon Light Source	Aesculap Inc	FSS	Class II	1999-02-01
K984084	Bardex Lubri-Sil Foley Catheter	Bard Medical Div.	EZL	Class II	1999-02-01
K983901	Ksea HF-Snare	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1999-02-01
K983897	Cervical Anesthesia Needle, Contracervical Anesthesia Needle, Model #'S 720209 30Gau X 4 Mm, 720210 30Gau X 6Mm, 720208G	Ri Mos. S.r.l.	HEE	Class II	1999-02-01
K983642	Cook Mini-Incubator	Cook Ob/Gyn	MQG	Class II	1999-02-01
K982751	Implex Screw and Washer System	Implex Corp.	MBI	Class II	1999-02-01
K982750	Corsaire	Optiway, Inc.	ITI	Class II	1999-02-01
K982559	Guidewire	Galt Medical Corp	DQX	Class II	1999-02-01
K982385	Porous Media Dpb20 Series Disposable Pre-Bypass Filter	Pentair Filtration Solutions	KRJ	Class II	1999-02-01
K982324	Vectra Pro Models 2 and 4	Chattanooga Group, Inc.	GZJ	Class II	1999-02-01
K982321	Vectra Stim Models 200 and 400	Chattanooga Group, Inc.	GZJ	Class II	1999-02-01
K982317	Vectra Combo	Chattanooga Group, Inc.	IMG	Class II	1999-02-01