# K982652: Allegiance Porta-Warm Mattress

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Jan 21, 1999 after 175 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: 1 generation back to K934631 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950680: Infant Heel Warmer, Baxter Healthcare Corp (1995). Our OCR of the scanned summary read K950860, FDA’s number for Permalute (Ultradent Products, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Allegiance Porta-Warm™ Mattress”.
- K934631: Transwarmer, Prism Technologies, Inc. (1994) Summary page 1.
- (no number) Prism Technologies, Inc. Transwarmer™: named in the summary without a submission number

## Most influential descendants
- K021843: Eyefeel Ophthalmic Warmer (2002), 1 descendant of its own
- K082087: Eyefeel Ophthalmic Warmer (2008), 0 descendants of its own

## Indications for use
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.

Source page: https://510kreport.com/device/K982652
Methodology: https://510kreport.com/methodology