510(k) · Cleared
ClearedAllegiance Porta-Warm Mattress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · IMD Pack, Hot Or Cold, Disposable
Cleared on Jan 21, 1999 as substantially equivalent to K950680 (Baxter Healthcare Corp, 1995) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 21, 1999
- Review
- 175 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934631 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934631 TranswarmerPrism Technologies, Inc. · 1994 · Recalled
- This deviceK982652 Allegiance Porta-Warm MattressAllegiance Healthcare Corp. · 1999
- Descendant · cites it directly · 1 of its ownK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934631 | Transwarmer | Prism Technologies, Inc. | 1994 | 2 |
| 0 (this device) | K982652 | Allegiance Porta-Warm Mattress | Allegiance Healthcare Corp. | 1999 | — |
| +1 | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| +2 | K082087 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950680 | Infant Heel Warmer Our OCR of the scanned summary read K950860, FDA’s number for Permalute (Ultradent Products, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Allegiance Porta-Warm™ Mattress”. | 1995 |
| * | K934631 | TranswarmerSummary page 1…ame: Hot Pack Classification: Cold and Hot Disposable Pack Predicate Device: Preamendment Allegiance Porta-Warm™ Mattress (K950860) Allegiance Infant Heel™ Warmer (K934631) Prism Technologies, Inc. Transwarmer™ Description: The. Porta-Warm™ Mattress consists of a heat source housed in a plastic pouc… | 1994 |
| * | — | Prism Technologies, Inc. Transwarmer™ Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021843 | Eyefeel Ophthalmic Warmer | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982652: Allegiance Porta-Warm Mattress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982652
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026