# K012512: Setpoint Endovascular Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Medical
- Decided: Jun 11, 2002 after 309 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- 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
Longest line of descent: 1 generation back to K811742 (1981). 7 ancestors in all.
27 later devices descend from it; 7 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003724: Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B, Medtronic Vascular (2000)
- K894980: Bio-Cal 370 Heater/Cooler, Bio Medicus, Inc. (1989) Summary page 1.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 1.
- K811742: Hemotherm Model 400, Cincinnati Sub-Zero (1981). Our reading of the summary gave K511742, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cincinnati Sub-zero Hemotherm 400”.
- K010338: Artic Sun Temperature Management System, Model 200, Medivance, Inc. (2001)
- K904404: Multi-Lumen Central Venous Catheter Set, Arrow Intl., Inc. (1991) Summary page 1.
- K890484: HI-LO Temp General Purpose Temperature Probe, Mallinckrodt Anesthesia Products (1989) Summary page 2.

## Cited in the summary but kept off the family tree
- K573745: Bair Hugger Patient Warming System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## 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

## Indications for use
The SetPoiiitO System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care,

Source page: https://510kreport.com/device/K012512
Methodology: https://510kreport.com/methodology