# K232638: FilteredFlo Warming Blankets

- Pathway: 510(k) (Traditional)
- Applicant: Iob Medical, Inc.
- Decided: Oct 24, 2023 after 55 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: 4 generations back to K021473 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231596: IOB Temperature Management System, Iob Medical, Inc. (2023) Summary page 4.

## Indications for use
The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

Source page: https://510kreport.com/device/K232638
Methodology: https://510kreport.com/methodology