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Thermedx, LLC

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Fluid Management System	P2000	FDA UDI	Class II	Active
Luer Lock Set, Single Lumen	LL0002	FDA UDI	Class II	Active
High Pressure Luer Lock Set, Single Lumen 300mmHg	HLL003	FDA UDI	Class II	Unknown
Tubing Set - Single Lumen, Inflow with Dual Outflow	LL0004	FDA UDI	Class II	Active
Urology Set	LL0006	FDA UDI	Class II	Active
Fluid Management System	W2100	FDA UDI	Class II	Active
Thermedx Fluid Managment System	K133799	FDA 510(k)	Class II	Active
FluidSmart	K172048	FDA 510(k)	Class II	Active
Thermedx 37-5 Electrocautery Probes, Models Mpj200, Mpj210, Mps220, Mpn230, Bph240	K102275	FDA 510(k)	Class II	Active
X-FLO Fluid Management System	K210628	FDA 510(k)	Class II	Active
Thermedx Prodigy Fluid Management System, Models P1000, P2000	K091939	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 1, 2014	Z-1463-2015	—	terminated	To correct software bugs that could affect the ability to accurately measure fluid deficit.
Feb 10, 2014	Z-2555-2014	—	terminated	A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.