# K921395: Hot Sack

- Pathway: 510(k) (Traditional)
- Applicant: C.F. Electronics, Inc.
- Decided: Sep 2, 1992 after 162 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- 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
- K120860: Infu Box Type 0412A (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K921395
Methodology: https://510kreport.com/methodology