# K231596: IOB Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Jun 30, 2023 after 29 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: 3 generations back to K021473 (2002). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162679: IOB Temperature Management System, Iob Medical, Inc. (2017) Summary page 4.
- K190221: IOB Warming Blankets, Iob Medical, Inc. (2019) Summary page 4.
- K221669: IOB Warming Blankets, Iob Medical, Inc. (2022) Summary page 4.

## Most influential descendants
- K252861: Warming System (2026), 0 descendants of its own
- K232638: FilteredFlo Warming Blankets (2023), 0 descendants of its own

## Indications for use
The IOB Temperature Management System Model IOB-507 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/K231596
Methodology: https://510kreport.com/methodology