# K936084: Omni Warm Gel Packs

- Pathway: 510(k) (Traditional)
- Applicant: Omni Therm, Inc.
- Decided: Mar 31, 1994 after 100 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 6 (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
- Nov 29, 2021 · Class II · Z-0508-2022: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold
- Nov 29, 2021 · Class II · Z-0506-2022: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold
- Nov 29, 2021 · Class II · Z-0509-2022: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold
- Nov 26, 2021 · Class II · Z-0505-2022: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold
- Feb 10, 2016 · Class II · Z-1316-2016: eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its spec
- Nov 20, 2015 · Class II · Z-0543-2016: Heel warmers may cause first and second degree burns.

Source page: https://510kreport.com/device/K936084
Methodology: https://510kreport.com/methodology