510(k) · Cleared
ClearedMistral-Air® Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgical Company International B.V., doing business as TSC Life · DWJ System, Thermal Regulating
Cleared on Aug 7, 2026 as substantially equivalent to K171234 (The Surgical Company International BV (As the 37company), 2017) after a 99-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 7, 2026
- Review
- 99 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942599 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK942599 Warm Air Warming UnitCincinnati Sub-Zero Products, Inc. · 1995 · Recalled
- 2 generations backK101705 Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010 · Recalled
- 1 generation backK171234 Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017
- This deviceK261437 Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942599 | Warm Air Warming Unit | Cincinnati Sub-Zero Products, Inc. | 1995 | 3 |
| −2 | K101705 | Mistral-Air Warming System | The Surgical Company International B.V. | 2010 | 1 |
| −1 | K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017 | — |
| 0 (this device) | K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 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 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 |
|---|---|---|---|
| * | K171234 | Mistral-Air Warming UnitSummary page 5…Mistral-Air® Warming System Model: MA1200 (Warming Unit) 510(k) Number: K171234 This predicate has not been subject to a design-related recall.… | 2017 |
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 31 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Mistral-Air® Warming System is indicated for patient warming in situations where prevention of inadvertent hypothermia is required.
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/K261437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261437: Mistral-Air® Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261437
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026