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 2331 of 3531

510(k) clearances, page 2331 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925586	Detectabuse(tm)	Biochemical Diagnostic, Inc.	DIF	Class I	1992-12-28
K925436	Medix Biotech Total T3 Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CDP	Class II	1992-12-28
K925257	Ciba Corning Acs T Uptake Immunoassay	Ciba Corning Diagnostics Corp.	KHQ	Class II	1992-12-28
K925251	Lixi Imaging Scope. Modification	Lixi, Inc.	JAA	Class II	1992-12-28
K925208	Ortho Hsv Antigen Elisa Test, Modification	Ortho Diagnostic Systems, Inc.	LGC	Class II	1992-12-28
K925132	Becton Dickinson Thyroid Stimulating Hormone Syste	Becton Dickinson Advanced Diagnostics	JLW	Class II	1992-12-28
K925105	Philips Medio Cp Family	Philips North America LLC	IZO	Class I	1992-12-28
K925096	Conceive One-Step Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1992-12-28
K924862	Aia-Pack Hcg Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1992-12-28
K924853	Aia-Pack Bhcg Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1992-12-28
K924365	Vacuplus Tubes with Brick Red Stoppers	Starplex Scientific Corp.	JKA	Class II	1992-12-28
K924151	Bisco D/c Resinomer	Bisco, Inc.	EBF	Class II	1992-12-28
K924137	Csp-a (Ceiling Suspended Positioner-Angio)	Fischer Imaging Corp.	IZI	Class II	1992-12-28
K924113	Abuscreen Online for Cocaine Metabolite	Roche Diagnostic Systems, Inc.	DLN	Class II	1992-12-28
K924020	Electrophoresis Tank	The Binding Site	JJN	Class I	1992-12-28
K923959	Albumin Test	Em Diagnostic Systems, Inc.	CIX	Class II	1992-12-28
K923587	Glucose Test System	Polymer Technology Corp.	CGA	Class II	1992-12-28
K923455	Hfg 350, 650, 1050	Varian Canada, Inc.	KPR	Class II	1992-12-28
K923438	Boston Conditioning Solution	Polymer Technology Corp.	LPN	Class II	1992-12-28
K923163	Rubber Dam Clamp	Aseptico, Inc.	EIE	Class I	1992-12-28
K922171	Centra II Analysis System	Marquette Electronics, Inc.	DQK	Class II	1992-12-28
K913724	Sonex Ultrasonic Tooth Brush	Sonex Intl., Corp.	JEQ	Class I	1992-12-28
K925619	Disposable Hand-Switching Esu Pencil	Beacon Laboratories, Inc.	GEI	Class II	1992-12-24
K925437	Acufex Cannulated Bone Tunnel Plugs	Cufex Microsurgical, Inc.	HRX	Class II	1992-12-24
K924999	Autopole Regulator System	Escalon Trek Medical	KYG	Class I	1992-12-24
K924653	Model #Qbc-17, 17Cm. Quadrature Breast Coil	Mri Devices Corp.	LNH	Class II	1992-12-24
K924479	Magnetic Resonance Diagnostic Device Accessories	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-12-24
K924331	Transystem Liquid Stuart Medium	Pro-Lab Diagnostics	LIO	Class I	1992-12-24
K924330	Transystem Amies with Charcoal	Pro-Lab Diagnostics	LIO	Class I	1992-12-24
K924329	Transystem Amies W/o Charcoal	Pro-Lab Diagnostics	LIO	Class I	1992-12-24
K924328	Transystem Liquid Amies Medium	Pro-Lab Diagnostics	LIO	Class I	1992-12-24
K923925	Hcg Stat-Pak	Chembio Diagnostic Systems, Inc.	JHI	Class II	1992-12-24
K923882	IV-Tube Secure	Ximedix, Inc.	FPA	Class II	1992-12-24
K923855	Sharpulse	Sharplan Lasers, Inc.	GEX	Class II	1992-12-24
K923423	Quadature Head/neck/vascular Coil	Medical Advances, Inc.	LNH	Class II	1992-12-24
K923140	Mrp-5000 and 7000 Bilateral/unilateral Tmj Coil	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1992-12-24
K922559	Acufex Endofix Button	Acufex Microsurgical, Inc.	EBG	Class II	1992-12-24
K922435	Laparoscopic Curved Triangle Retractor	Advanced Surgical, Inc.	GCJ	Class II	1992-12-24
K921653	Vectra Magnetic Resonance System	General Electric Co.	LNH	Class II	1992-12-24
K921595	Y-Type Blood Administration Set Model #Ht-Tr2	Haemotronic, Inc.	BRZ	Class II	1992-12-24
K921594	Haemotrol Model #Ht-Sb/6 Burette Set	Haemotronic, Inc.	FPA	Class II	1992-12-24
K921040	Endoscope	Origin Medsystems, Inc.	GCJ	Class II	1992-12-24
K920778	Omron Wrist Digital Blood Pressure Monitor Hem-601	Omron Healthcare Co., Ltd.	DXN	Class II	1992-12-24
K915190	Perfecta Total Hip System, Ha Coated	Orthomet, Inc.	MEH	Class II	1992-12-24
K926040	Heli-Tech Retrieval Basket	Cape Tech Medical Products	LQR	Class II	1992-12-23
K925702	Nichols Apo B Chemiluminescence Assay	Nichols Institute Diagnostics	MSJ	Class I	1992-12-23
K925495	Microvasive Insurg Helical & Mini-Helical Baskets	Boston Scientific Corporation	LQR	Class II	1992-12-23
K925032	3M Vitremer Tri-Cure Glass Ionomer System	3M Company	EMA	Class II	1992-12-23
K924487	Red Dot 2515 Cardiac Sensor System	3M Company	BRX	Class I	1992-12-23
K924398	Uni-Check Reagent Strip	Diagnostic Solutions, Inc.	CGA	Class II	1992-12-23