# K811742: Hemotherm Model 400

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero
- Decided: Aug 13, 1981 after 55 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 5 cite it directly.
0 of 56 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
- K012512: Setpoint Endovascular Temperature Management System (2002), 27 descendants of its own
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000 (2007), 20 descendants of its own
- K083662: Criticool (2009), 16 descendants of its own
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own

## Recalls of this device
- May 2, 2011 · Not classified · Z-2720-2011: The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact
- May 2, 2011 · Not classified · Z-2721-2011: The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact

Source page: https://510kreport.com/device/K811742
Methodology: https://510kreport.com/methodology