# K934631: Transwarmer

- Pathway: 510(k) (Traditional)
- Applicant: Prism Technologies, Inc.
- Decided: Feb 3, 1994 after 132 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982652: Allegiance Porta-Warm Mattress (1999), 2 descendants of its own
- K021843: Eyefeel Ophthalmic Warmer (2002), 1 descendant of its own
- K082087: Eyefeel Ophthalmic Warmer (2008), 0 descendants of its own

## Recalls of this device
- Jul 8, 2019 · Class II · Z-2364-2019: The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequen
- May 1, 2013 · Class II · Z-1397-2015: Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

Source page: https://510kreport.com/device/K934631
Methodology: https://510kreport.com/methodology