Data / Medical devices / United States / Medical Solutions, Inc.

Medical Solutions, Inc.: FDA-registered device maker in Chantilly, VA, United States, 9 510(k) clearances

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

Medical Solutions, Inc. is registered with the FDA (registration 1125615) in Chantilly, VA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 12, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1125615
FEI number: 3002930098
Address: 3901 Centerview Dr Ste L, Chantilly, VA, United States, 20151
Owner or operator: MEDICAL SOLUTIONS, INC. (9031861)
Roles: Complaint file establishment, Specification developer
First device listed: March 19, 1998
Registered through: 2026
Brand names listed: 16N1: 1 Liter Bag Warming System, 8N1: The 3 Liter Warming System, 986L, 986S, Heat Stack, MSI Pressure Infusor, MSI-1000L, MSI-1000L-12 and more

Devices it lists

Device	Product code	Class	Role	Source
Infusor, Pressure, For I.V. Bags	KZD	1	Specification developer	accessdata.fda.gov
LDQ	LDQ		Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Complaint file establishment	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	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 12, 2022	K202461	ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System	LGZ	Substantially Equivalent	Smisson-Cartledge Biomedical, LLC	accessdata.fda.gov
October 26, 2006	K052055	SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200	LGZ	Substantially Equivalent	Smisson-Cartledge Biomedical, LLC	accessdata.fda.gov
February 15, 2005	K041839	8NONE	LGZ	Substantially Equivalent	Medical Solutions, Inc.	accessdata.fda.gov
August 20, 2001	K012276	TEMP 3	LGZ	Substantially Equivalent	Medical Solutions, Inc.	accessdata.fda.gov
September 2, 1998	K981032	PIV SYSTEM	LDQ	Substantially Equivalent	Medical Solutions, Inc.	accessdata.fda.gov
July 10, 1998	K981509	TEMPO III	LGZ	Substantially Equivalent	Medical Products, Inc.	accessdata.fda.gov
March 10, 1998	K980086	HEAT STACK	LGZ	Substantially Equivalent	Medical Solutions, Inc.	accessdata.fda.gov
March 10, 1998	K973748	TEMPO AND TEMP H20	LGZ	Substantially Equivalent	Smith	accessdata.fda.gov
October 29, 1997	K973843	MSI PRESSURE INFUSOR	KZD	Substantially Equivalent	Smith Assoc.	accessdata.fda.gov

Compare with other makers

Updated August 12, 2022. 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.