# K811743: Maxitherm

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero
- Decided: Jul 16, 1981 after 27 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 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
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own
- K052443: Icy Catheter, Model IC-3893A (2005), 8 descendants of its own
- K070161: Quattro Catheter Model IC4593 (2007), 7 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own

Source page: https://510kreport.com/device/K811743
Methodology: https://510kreport.com/methodology