Data / Medical devices / United States / GVS TM, Inc.

GVS TM, Inc.: FDA-registered device maker in Covina, CA, United States, 4 510(k) clearances

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

GVS TM, Inc. is registered with the FDA (registration 3037389071) in Covina, CA, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 22, 1996. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch GVS TM, Inc.

FDA registration number: 3037389071
FEI number: 2013342
Address: 1630 W Industrial Park St, Covina, CA, United States, 91722
Owner or operator: GVS TM, Inc. (10093016)
Roles: Contract manufacturer, Manufacturer
First device listed: March 18, 2025
Registered through: 2027
Brand names listed: 400-03E, 430-40, 732-32M, 732-33M, 732-37M, 732-42M, 732-80, 732-82 and more

Devices it lists

Device	Product code	Class	Role	Source
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	JOD	2	Manufacturer	accessdata.fda.gov
Microfilter, Blood Transfusion	CAK	2	Manufacturer	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Manufacturer	accessdata.fda.gov
Set, Transfer (Blood/Plasma)	KSB	2	Manufacturer	accessdata.fda.gov
Supplies, Blood-Bank	KSS	1	Manufacturer	accessdata.fda.gov
System, Detection, Bacterial, For Platelet Transfusion Products	MZC	1	Manufacturer	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
April 22, 1996	K960993	PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)	CAK	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
February 29, 1988	K875095	PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE	JOD	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
January 6, 1988	K873667	PALL LEUKOCYTE REMOVAL FILTER, PLATELETS	CAK	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
January 6, 1988	K873666	PALL LEUKOCYTE REMOVAL FILTER, BLOOD	CAK	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 3, 2025	98145	Class II	Ongoing	SQ40S Blood Transfusion Filter	Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.	accessdata.fda.gov

Compare with other makers

Updated January 22, 2026. 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.