# K221669: IOB Warming Blankets

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Dec 27, 2022 after 201 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: 2 generations back to K021473 (2002). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K231596: IOB Temperature Management System (2023), 2 descendants of its own
- K252861: Warming System (2026), 0 descendants of its own
- K232638: FilteredFlo Warming Blankets (2023), 0 descendants of its own

## Indications for use
The IOB Warming Blankets are 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/K221669
Methodology: https://510kreport.com/methodology