# K970399: Kwik Kold Peri Cold Pack (Catalog Number TBD)

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Apr 3, 1997 after 59 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Allegiance Peri K™ Perineal Cold Pack: named in the summary without a submission number
- (no number) Jack Frost Perineal Cold Pack: named in the summary without a submission number
- (no number) Florida Medical Perineal Cool Comfort Pack: named in the summary without a submission number
- (no number) Hospital Medical Services Peri + Plus Peri Cold Pack: named in the summary without a submission number

## Most influential descendants
- K973770: Allegiance Kwik Heat Warm Perineal Pack (1997), 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
- K072082: Gumease Dental Mouthpiece (2007), 0 descendants of its own

## Indications for use
The Allegiance Kwik Kold™ Peri Cold Pack is an over-the-counter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.

Source page: https://510kreport.com/device/K970399
Methodology: https://510kreport.com/methodology