# K221653: InfaTherm Disposable Infant Warming Mattress

- Pathway: 510(k) (Traditional)
- Applicant: International Biomedical
- Decided: Oct 6, 2022 after 121 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- 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 K112547 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163295: Infant Transport Mattress Warmer with Disc, Rapid Aid Corp. (2017) Summary page 4.

## Indications for use
The InfaThermTM Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

Source page: https://510kreport.com/device/K221653
Methodology: https://510kreport.com/methodology