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 2026-11-02, 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 2422 of 3531

510(k) clearances, page 2422 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910341	Polaris	Pfizer Laser Systems	GEX	Class II	1991-10-11
K905211	Vidas Clostridium Difficile Toxin a (Cda) Assay	Vitek Systems, Inc.	LLH	Class I	1991-10-11
K913680	Berman Intubating/pharyngeal Airway	Chain Plastics Operations, Inc.	CAE	Class I	1991-10-10
K913643	Mucous Specimen Trap	Medical Device Inspection Company	BYZ	Class II	1991-10-10
K913297	Schneider Match-35(Tm) Percu Trans Angioplas Cath	Schneider Intl., Ltd.	LIT	Class II	1991-10-10
K913275	Venturi Oxygen Mask	Specialty Packaging Producs, Inc.	BYG	Class I	1991-10-10
K913263	Vitalmax 830 Series	Pace Tech, Inc.	MHX	Class II	1991-10-10
K913220	Aerosol Masks, 81426, 81476, 81490 & 81492	Specialty Packaging Producs, Inc.	CAF	Class II	1991-10-10
K913110	Pdm-1 Device:capd Disinfecting Device, Modified	Microwave Medical Systems, Inc.	DRQ	Class II	1991-10-10
K913028	Arthro-Flow Irrigation 2 System	Davol, Inc.	HRX	Class II	1991-10-10
K912652	Flex-Elbow	Vital Signs, Inc.	BZA	Class I	1991-10-10
K912382	Military Radiographic Flat Table, Cat # T-9130	Continental X-Ray Corp.	IXQ	Class II	1991-10-10
K912265	Medilase Semi-Rigid Instrod Sheath Series Ae1000	Medical Laser, Inc.	FED	Class II	1991-10-10
K911687	Ver-Med A10020 Resting EKG Electrode	Vermont Medical, Inc.	DRX	Class II	1991-10-10
K911662	Marquette Pediatric Defibrillation/pacing Pads	Marquette Electronics, Inc.	LDD	Class II	1991-10-10
K911472	Bio-Sensor 01 EKG Electrode	Bio-Sensor, Inc.	DRX	Class II	1991-10-10
K902920	Turbotron 20/20	Prestige Manufacturing Snd Bhd	LYL	Class II	1991-10-10
K914203	Laparoscopic Balloon Retractor	Origin Medsystems, Inc.	GCJ	Class II	1991-10-09
K914086	Ican Cylindrical Sponges	Icn Pharmaceuticals, Inc.	GDX	Class I	1991-10-09
K914083	Ican K Dissector Sponges	Icn Pharmaceuticals, Inc.	GDY	Class I	1991-10-09
K914081	Ican Cotton Rayon Balls	Icn Pharmaceuticals, Inc.	FRL	Class I	1991-10-09
K913978	Total Protein Reagent Beckman Synchron Cx3 Analyze	Beckman Instruments, Inc.	CEK	Class II	1991-10-09
K913947	Imperva Bond	Shofu Dental Corp.	EBF	Class II	1991-10-09
K913789	Aerobic Foam Swab Culturette(r)	BD Becton Dickinson Vacutainer Systems Preanalytic	JSM	Class I	1991-10-09
K913705	Abbott Qluickstart Iron Test, Item #5A29	Em Diagnostic Systems, Inc.	CFM	Class I	1991-10-09
K913699	Modern Materials Orthodontic Resin	Kulzer GmbH	EBI	Class II	1991-10-09
K913698	Accelar 20 Advance Rapid Cure Repair Material	Kulzer GmbH	EBI	Class II	1991-10-09
K913572	Autopack Non-Eugenol Periodontal Dressing	Specialites Septodont	EMA	Class II	1991-10-09
K913535	A-Dec Decade 1020 Chair	A-dec, Inc.	KLC	Class I	1991-10-09
K913118	Glaucoma-Scope	Ophthalmic Imaging Systems	HLI	Class II	1991-10-09
K913113	Fst Cath-Ud Catheter, Modification	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1991-10-09
K913061	Fibrinogen Determination Kit	Sigma Diagnostics, Inc.	GIS	Class II	1991-10-09
K913025	Abbott Quickstart Albumin Bcp (Albp)#5a16	Em Diagnostic Systems, Inc.	CJW	Class II	1991-10-09
K913022	Cci Videokeratoscope/comparator	Cci	HLQ	Class I	1991-10-09
K912876	Fibrinostika Fbdp Microelisa System	bioMerieux, Inc.	DAP	Class II	1991-10-09
K912711	Il Test Proclot Assay Stystem	Instrumentation Laboratory Co.	GGP	Class II	1991-10-09
K912160	Butterfly Dressing	Durden Enterprises, Inc.	KGX	Class I	1991-10-09
K912050	Novoste Vessel Dilater	Novaste Corp.	DRE	Class II	1991-10-09
K912008	Tru-View Multi-Channel Display	General Devices	DRT	Class II	1991-10-09
K911981	Hemocard Hemoglobin S	Isolab, Inc.	GHM	Class II	1991-10-09
K911285	Pulpdent Polyamide Dentin Liner	Pulpdent Corporation	EME	Class I	1991-10-09
K911043	Hemisphere Multiplane Endorectal Probe	Pie Medical Equipment B.V.	ITX	Class II	1991-10-09
K904747	Pei Plaque Electrode Array	Prucka Engineering, Inc.	DRF	Class II	1991-10-09
K913914	Proguardii(tm) Blood Collection Device	Care Medical Devices, Inc.	FMI	Class II	1991-10-08
K913841	2 Lumen Endos Retro Cholangiopancrea Injec Cath	Endovations	FGE	Class II	1991-10-08
K913733	Sterile Chest Tube	Vascular Products, Inc.	GBW	Class I	1991-10-08
K913721	Fst Cath - Ui Usrodynamic Cath Introducer System	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1991-10-08
K913586	Marlow Verres Needles	Marlo Surgical Technology	GCT	Class II	1991-10-08
K913479	Wound Care Tray B	Catalina Biomedical Corp.	MCY	Class II	1991-10-08
K913424	Staclot(r) Protein S Test Kit	American Bioproducts Co.	GGP	Class II	1991-10-08