# K162679: IOB Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Apr 28, 2017 after 214 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
Longest line of descent: 1 generation back to K021473 (2002). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021473: Bair Hugger Temperature Management System, Augustine Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K190221: IOB Warming Blankets (2019), 4 descendants of its own
- K221669: IOB Warming Blankets (2022), 3 descendants of its own
- K231596: IOB Temperature Management System (2023), 2 descendants of its own
- K262089: Disposable Warming Blanket (2026), 0 descendants of its own
- K252861: Warming System (2026), 0 descendants of its own

## Indications for use
The IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

Source page: https://510kreport.com/device/K162679
Methodology: https://510kreport.com/methodology