510(k) · Cleared
ClearedCovidien Warmtouch Convective Warming Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · DWJ System, Thermal Regulating
Cleared on Apr 17, 2013 as substantially equivalent to K020604 (Nellcor Puritan Bennett, Inc., 2002) after a 198-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Apr 17, 2013
- Review
- 198 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913016 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DWJ? 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 DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020604 | Warmtouch Patient Warming System, Model 5300Summary page 2…WarmTouch TM Model 5300A Patient Warming System Device Common Name: Thermal Regulating System 510(k) Number: K020604 (cleared April 2002) Manufacturer: Covidien, formerly Nellcor Puritan Bennett,… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, 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 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123083: Covidien Warmtouch Convective Warming Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123083
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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