510(k) · Cleared
Recalled · Class II · 2019Transwarmer
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 Feb 3, 1994 after a 132-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 3, 1994
- Review
- 132 days
- Class
- Class I
- Product code
- IMD
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK934631 TranswarmerPrism Technologies, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK982652 Allegiance Porta-Warm MattressAllegiance Healthcare Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934631 | Transwarmer | Prism Technologies, Inc. | 1994 | — |
| +1 | K982652 | Allegiance Porta-Warm Mattress | Allegiance Healthcare Corp. | 1999 | — |
| +2 | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| +3 | K082087 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982652 | Allegiance Porta-Warm Mattress | 1999 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2019 | Class II | Z-2364-2019 | Error in labeling | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products… |
| May 1, 2013 | Class II | Z-1397-2015 | Package design/selection | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982652 (Allegiance Healthcare Corp., 1999) has gone furthest, with 2 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/K934631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934631: Transwarmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934631
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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