# K140623: Nxstage Express Fluid Warmer

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Jun 16, 2014 after 97 days
- Product code: FLA (Monitor, Temperature, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001283 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071263: Nxstage Travel Warmer, Models TW-400 & FWS-500, Nxstage Medical, Inc. (2007) Summary page 2.

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

Source page: https://510kreport.com/device/K140623
Methodology: https://510kreport.com/methodology