# K894980: Bio-Cal 370 Heater/Cooler

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medicus, Inc.
- Decided: Nov 2, 1989 after 86 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 1 cites it directly.
0 of 29 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
- 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

## Recalls of this device
- Feb 8, 2018 · Class II · Z-0900-2018: Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has 

Source page: https://510kreport.com/device/K894980
Methodology: https://510kreport.com/methodology