# K071263: Nxstage Travel Warmer, Models TW-400 & FWS-500

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Aug 24, 2007 after 109 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001283 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012832: Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable Warming Set, Model #FWS-200, Nxstage Medical, Inc. (2001) Summary page 1.
- K020858: Nxstage Therapy System, Nxstage Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K140623: Nxstage Express Fluid Warmer (2014), 0 descendants of its own

## Recalls of this device
- Jun 11, 2018 · Class II · Z-2793-2018: There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of

## Indications for use
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.

Source page: https://510kreport.com/device/K071263
Methodology: https://510kreport.com/methodology