# K883603: Sarns Temp. Control and Monitor System (TCM II)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Nov 3, 1988 after 72 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K031544: Heater Cooler Unit, Model Hcu 30 (2003), 7 descendants of its own
- K052601: Stockert Heater-Cooler System 3T (2006), 4 descendants of its own
- K191402: Heater-Cooler System 3T (2020), 1 descendant of its own
- K220635: Heater-Cooler System 3T (2022), 0 descendants of its own
- K212657: Quantum Heater-Cooler (2022), 0 descendants of its own

## Recalls of this device
- Apr 16, 2021 · Class II · Z-1791-2021: Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it
- Mar 16, 2018 · Class II · Z-1418-2018: Update to cooler-heater cleaning instructions.
- Jun 8, 2016 · Class II · Z-2209-2016: Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced
- May 30, 2013 · Class II · Z-1569-2013: Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

Source page: https://510kreport.com/device/K883603
Methodology: https://510kreport.com/methodology