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Global Life Sciences Solutions USA LLC: FDA-registered device maker in Marlborough, MA, United States, 15 510(k) clearances

Name: Global Life Sciences Solutions USA LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Global Life Sciences Solutions USA LLC is registered with the FDA (registration 3012821221) in Marlborough, MA, United States. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012821221
Address: 100 Results Way, Marlborough, MA, United States, 01752
Owner or operator: Global Life Sciences Solutions USA LLC (1831947)
Roles: Complaint file establishment, Specification developer
First device listed: April 5, 2023
Registered through: 2026
Brand names listed: Anesthesia Breathing Circuit - Adult Kit 40 Coax; Anesthesia Breathing Circuit - Adult Kit 60 Coax; Anesthesia Breathing, Briostor Transfer/Freezing Bag Set, Cell Wash/Infusion Bag; Thermogenesis Cell Wash/Infusion Bag, Conserve Small Volume HME Filter; Ultipor 100 Breathing System Filter; Ultipor 100 Breathing System Filter with CO2 Moni, Freezing Bag; Thermogenesis Freezing Bag, Gardian 25mm Syringe Filter, LaparoShield Laparoscopic Smoke Filter; LaparoShield Plus Laparoscopic Smoke Filter, Lipipor NLF1A NLF2A NLF2NTA TNA2A Infusion Filters and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cord Blood Processing System And Storage Container	OAO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Water Purification, General Medical Use	NHV	2	Complaint file establishment, 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
August 31, 2026	K261403	Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter	FPB	Substantially Equivalent	Global Life Sciences Solutions USA, LLC	accessdata.fda.gov
November 16, 2021	K211286	Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger	CAH	Substantially Equivalent	Pall Corporation	accessdata.fda.gov
June 1, 2017	K163609	Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)	NHV	Substantially Equivalent	Pall International Sarl	accessdata.fda.gov
June 10, 2016	K153434	Pall-Aquasafe Water Filter	NHV	Substantially Equivalent	Pall International Sarl	accessdata.fda.gov
August 1, 2002	K013093	PALL ULTIPOR ANESTHESIA BREATHING SYSTEM	CAH	Substantially Equivalent	Pall Medical	accessdata.fda.gov
December 16, 1999	K993379	PALL SUPOR AEF FILTER	FPB	Substantially Equivalent	Pall Corp.	accessdata.fda.gov
August 20, 1999	K992361	PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1	FYD	Substantially Equivalent	Pall Medical	accessdata.fda.gov
September 6, 1994	K941589	SYRINGE FILTER DEVICES	FMF	Substantially Equivalent	Gelman Sciences, Inc.	accessdata.fda.gov
July 26, 1994	K942275	VIAL VENT FILTER	FPB	Substantially Equivalent	Gelman Sciences, Inc.	accessdata.fda.gov
June 13, 1991	K905794	PALL 3N1 FILTER	FPB	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
November 7, 1985	K854062	PALL PULMONARY FUNCTION FILTER	BZG	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
April 9, 1985	K850825	AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR	FPB	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
September 16, 1981	K812505	PALL ULTIPOR VACUUM LINE BACTERIA FITLER	JQC	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov
January 21, 1981	K802765	ACRODISC FILTER ASSEMBLY	FPB	Substantially Equivalent	Gelman Sciences, Inc.	accessdata.fda.gov
August 3, 1979	K791307	UNIPOR BREATHING CIRCUIT FILTER	CAH	Substantially Equivalent	Pall Biomedical Products Co.	accessdata.fda.gov

Compare with other makers

Updated August 31, 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.