# K002409: Maxone, Blood, Blood Products and IV Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Automatic Medical Technologies, Inc.
- Decided: Jun 28, 2001 after 325 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012832: Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable Warming Set, Model #FWS-200 (2001), 2 descendants of its own
- K071263: Nxstage Travel Warmer, Models TW-400 & FWS-500 (2007), 1 descendant of its own
- K060851: Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser (2006), 1 descendant of its own
- K140623: Nxstage Express Fluid Warmer (2014), 0 descendants of its own
- K120860: Infu Box Type 0412A (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K002409
Methodology: https://510kreport.com/methodology