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Duopross Meditech Corporation: FDA-registered device maker in Farmingdale, NY, United States, 11 510(k) clearances

Name: Duopross Meditech Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Duopross Meditech Corporation is registered with the FDA (registration 3003681915) in Farmingdale, NY, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 17, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3003681915
Address: 154 Marine St, Farmingdale, NY, United States, 11735
Owner or operator: DUOPROSS MEDITECH CORP (9055828)
Roles: Specification developer
First device listed: April 24, 2017
Registered through: 2026
Brand names listed: DPS, bak'snap, baksnap, insosafe, safetytray

Devices it lists

Device	Product code	Class	Role	Source
Needle, Hypodermic, Single Lumen	FMI	2	Specification developer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Specification developer	accessdata.fda.gov
Tube, Feeding	FPD	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 17, 2025	K252518	DuoprossTM Smart Cap (Type I)	FMF	Substantially Equivalent	Duopross Meditech Corporate	accessdata.fda.gov
June 14, 2010	K100099	ORAL/ENTERAL SYRINGES	FPD	Substantially Equivalent	Philips Children'S Medical Ventures	accessdata.fda.gov
December 5, 2005	K052445	DUOPROSS NEEDLE	FMI	Substantially Equivalent	Duopross Meditech Corporation	accessdata.fda.gov
November 9, 2005	K052075	PROCEDUR-10	FMF	Substantially Equivalent	Avanca Medical Devices, Inc.	accessdata.fda.gov
April 5, 2005	K050131	INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE	MEG	Substantially Equivalent	M.K. Meditech Co. , Ltd.	accessdata.fda.gov
February 22, 2005	K042500	DUOPROSS SYRINGES	FMF	Substantially Equivalent	Duopross Meditech Corporation	accessdata.fda.gov
January 21, 2005	K042487	PROCEDUR SF SAFETY SYRINGE DEVICE	MEG	Substantially Equivalent	Avanca Medical Devices, Inc.	accessdata.fda.gov
January 21, 2004	K034031	10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE	MEG	Substantially Equivalent	M.K. Meditech Co. , Ltd.	accessdata.fda.gov
June 6, 2003	K031594	BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY	MEG	Substantially Equivalent	M.K. Meditech Co. , Ltd.	accessdata.fda.gov
September 19, 2002	K022806	DUOPRO SAFETY SYRINGE (DUOPROSS)	MEG	Substantially Equivalent	M.K. Meditech Co. , Ltd.	accessdata.fda.gov
May 2, 2002	K020623	DUOPRO SAFETY SYRINGE (DUOPROSS)	MEG	Substantially Equivalent	M.K. Meditech Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.