Data / Medical devices / United States / WellPact

WellPact: FDA-registered device maker in Roaring Spring, PA, United States, 4 510(k) clearances

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

WellPact is registered with the FDA (registration 3030896267) in Roaring Spring, PA, United States. It lists 10 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030896267
Address: 508 Robinson Avenue, Roaring Spring, PA, United States, 16673
Owner or operator: NPC Inc. (10094953)
Roles: Repackager or relabeler
First device listed: January 9, 2026
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Automated Occult Blood Analyzer	OOX	2	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Blood Collection Device For Cell-Free Nucleic Acid	QMA	2	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	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
July 26, 2024	K231776	Cell-Free DNA BCT	QMA	Substantially Equivalent	Streck, Inc.	accessdata.fda.gov
February 2, 2024	K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 12, 2022	K221126	Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets	FMK	Substantially Equivalent	Owen Mumford, Ltd.	accessdata.fda.gov
October 21, 2004	K041408	POLYMEDCO OC AUTO MICRO 80 FOB TEST	OOX	Substantially Equivalent	Polymedco, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 26, 2024. 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.