# K973770: Allegiance Kwik Heat Warm Perineal Pack

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Nov 13, 1997 after 42 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 K970399 (1997). 1 ancestor in all.
2 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)
- K970399: Kwik Kold Peri Cold Pack (Catalog Number TBD), Allegiance Healthcare Corp. (1997) Summary page 2.
- (no number) Jack Frost Perineal Pad (Warm): named in the summary without a submission number
- (no number) H.M.S.™ Peri Warm™ Perineal Pack: named in the summary without a submission number
- (no number) Allegiance Preamendment Small Hot Pack: 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. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an episiotomy.

Source page: https://510kreport.com/device/K973770
Methodology: https://510kreport.com/methodology