510(k) · Cleared
Recalled · Class II · 2015Instant Warm Gel Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prism Technologies, Inc. · IMD Pack, Hot Or Cold, Disposable
Cleared on Oct 2, 1991 after a 106-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 4 times.
- Decided
- Oct 2, 1991
- Review
- 106 days
- Class
- Class I
- Product code
- IMD
- Recalls
- 4
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK912715 Instant Warm Gel PackPrism Technologies, Inc. · 1991
- 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) | K912715 | Instant Warm Gel Pack | Prism Technologies, Inc. | 1991 | — |
| +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 |
|---|---|---|---|---|
| Jan 26, 2015 | Class II | Z-1301-2015 | Package design/selection | Products without expiration date have the remote potential for minor burn |
| Jan 26, 2015 | Class II | Z-1299-2015 | Package design/selection | Products without expiration date have the remote potential for minor burn |
| Jan 26, 2015 | Class II | Z-1300-2015 | Package design/selection | Products without expiration date have the remote potential for minor burn |
| Jan 26, 2015 | Class II | Z-1298-2015 | Package design/selection | Products without expiration date have the remote potential for minor burn |
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/K912715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912715: Instant Warm Gel Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912715
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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