# K012832: Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable Warming Set, Model #FWS-200

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Oct 24, 2001 after 62 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973741 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973741: Bair Hugger Blood/Fluid Warmer, Augustine Medical, Inc. (1998) Summary page 4.
- K002409: Maxone, Blood, Blood Products and IV Fluid Warmer, Automatic Medical Technologies, Inc. (2001) Summary page 4.

## Cited in the summary but kept off the family tree
- K950038: Medi-Temp II FW300 Blood/Fluid Warmer (originally cleared as the Dupaco CounterFlo 300 Blood/Fluid Warmer System). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Most influential descendants
- K071263: Nxstage Travel Warmer, Models TW-400 & FWS-500 (2007), 1 descendant of its own
- K140623: Nxstage Express Fluid Warmer (2014), 0 descendants of its own

## Indications for use
The ComfortMate™ Filuid Warming System is intended to be used for the warming of fluids prior to administration.

Source page: https://510kreport.com/device/K012832
Methodology: https://510kreport.com/methodology