# K912715: Instant Warm Gel Pack

- Pathway: 510(k) (Traditional)
- Applicant: Prism Technologies, Inc.
- Decided: Oct 2, 1991 after 106 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K032989: Medi-Heat Infant Heel Warmer (2003), 4 descendants of its own
- K040856: Rapid Aid Instant Disposable Infant Heel Warmer (2004), 3 descendants of its own
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer (2015), 2 descendants of its own
- K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (2016), 1 descendant of its own
- K221154: Infant Heel WarmerTM; Heel Snuggler® (2022), 0 descendants of its own

## Recalls of this device
- Jan 26, 2015 · Class II · Z-1301-2015: Products without expiration date have the remote potential for minor burn
- Jan 26, 2015 · Class II · Z-1299-2015: Products without expiration date have the remote potential for minor burn
- Jan 26, 2015 · Class II · Z-1300-2015: Products without expiration date have the remote potential for minor burn
- Jan 26, 2015 · Class II · Z-1298-2015: Products without expiration date have the remote potential for minor burn

Source page: https://510kreport.com/device/K912715
Methodology: https://510kreport.com/methodology