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Millyard Advanced Medical Products LLC: FDA-registered device maker in Manchester, NH, United States, 8 510(k) clearances

Name: Millyard Advanced Medical Products LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Millyard Advanced Medical Products LLC is registered with the FDA (registration 3047799708) in Manchester, NH, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 1, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3047799708
Address: 350 Gay St, Manchester, NH, United States, 03103
Owner or operator: Millyard Advanced Medical Products LLC (10072764)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 1, 2020
Registered through: 2027
Brand names listed: Remunity Pump for Remodulin (treprostinil) Injection, Remunity System, Remunity" Pump for Remodulin (treprostinil) Injection, Twiist Automated Insulin Delivery System, iiSure Infusion Set, twiist Automated Insulin Delivery System

Devices it lists

Device	Product code	Class	Role	Source
Alternate Controller Enabled Insulin Infusion Pump	QFG	2	Manufacturer	accessdata.fda.gov
Infusion Pump, Drug Specific, Pharmacy-Filled	QJY	2	Manufacturer	accessdata.fda.gov
Interoperable Automated Glycemic Controller	QJI	2	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer, Repackager or relabeler	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
August 1, 2025	K243841	Sparta Infusion Set for Insulin	FPA	Substantially Equivalent	Deka Research and Development	accessdata.fda.gov
April 2, 2025	K250930	twiist system	QFG	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
March 11, 2025	K250357	RemunityPRO Pump for Remodulin® (treprostinil) Injection	FRN	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
January 16, 2025	K241736	Remunity 2.0 Pump for Remodulin (treprostinil) Injection	FRN	Substantially Equivalent	Deka Research and Development Corp.	accessdata.fda.gov
November 27, 2024	K243354	Remunity System	QJY	Substantially Equivalent	Deka Research & Development Corp.	accessdata.fda.gov
March 13, 2024	K234055	DEKA Loop	QJI	Substantially Equivalent	Deka Research and Development	accessdata.fda.gov
February 21, 2020	K191313	Unity Subcutaneous Infusion System for Remodulin	QJY	Substantially Equivalent	DEKA Research & Development	accessdata.fda.gov
October 7, 2004	K042172	CLEO 90 INFUSION SET	FPA	Substantially Equivalent	Smiths Medical MD, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 1, 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.