510(k) · Cleared
Recalled · Class II · 2021Omni Warm Gel Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Therm, Inc. · IMD Pack, Hot Or Cold, Disposable
Cleared on Mar 31, 1994 after a 100-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 31, 1994
- Review
- 100 days
- Class
- Class I
- Product code
- IMD
- Recalls
- 6
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK936084 Omni Warm Gel PacksOmni Therm, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- Descendant · 3 generations on · 1 of its ownK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
Most influential descendants
Showing 5 of 5 · See all- K032989Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003 · cites it directly4descendants
- K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004 · cites it directly3descendants
- K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015 · 2 generations on2descendants
- K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc. · 2016 · 3 generations on1descendant
- K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936084 | Omni Warm Gel Packs | Omni Therm, Inc. | 1994 | — |
| +1 | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| +1 | K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid, Ltd. | 2004 | — |
| +2 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015 | — |
| +3 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| +4 | K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IMD device
- #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2021 | Class II | Z-0508-2022 | No Marketing Application | 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 without new 510(k) clearance. |
| Nov 29, 2021 | Class II | Z-0506-2022 | No Marketing Application | 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 without new 510(k) clearance. |
| Nov 29, 2021 | Class II | Z-0509-2022 | No Marketing Application | 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 without new 510(k) clearance. |
| Nov 26, 2021 | Class II | Z-0505-2022 | No Marketing Application | 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 without new 510(k) clearance. |
| Feb 10, 2016 | Class II | Z-1316-2016 | Labeling design | 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 specification. |
| Nov 20, 2015 | Class II | Z-0543-2016 | Labeling design | Heel warmers may cause first and second degree burns. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032989 (Mediheat, Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IMD devicesIMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMD
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IMD
Too few IMD 510(k)s in any year since 2007 to give a median.
Recalls per year · IMD
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMD
66in 2025
MAUDE reports naming product code IMD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 211 |
| 2008 | 1 | — | 4 | 804 |
| 2009 | 0 | — | 0 | 210 |
| 2010 | 0 | — | 1 | 58 |
| 2011 | 0 | — | 0 | 70 |
| 2012 | 1 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 1 | 193 |
| 2016 | 0 | — | 0 | 213 |
| 2017 | 1 | — | 0 | 234 |
| 2018 | 0 | — | 3 | 262 |
| 2019 | 0 | — | 0 | 632 |
| 2020 | 0 | — | 0 | 248 |
| 2021 | 0 | — | 4 | 142 |
| 2022 | 1 | — | 0 | 202 |
| 2023 | 0 | — | 0 | 184 |
| 2024 | 0 | — | 0 | 112 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K936084: Omni Warm Gel Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936084
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026