510(k) · Cleared
ClearedSoft Air, Model SA 4000 and Mistral Air, Model MA0100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adroit Medical Systems, Inc. · DWJ System, Thermal Regulating
Cleared on Jun 6, 2008 after a 158-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 6, 2008
- Review
- 158 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK073712 Soft Air, Model SA 4000 and Mistral Air, Model MA0100Adroit Medical Systems, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK101705 Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK171234 Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017
- Descendant · 3 generations on · 0 of its ownK261437 Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
Most influential descendants
Showing 3 of 3 · See all- K101705Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010 · cites it directly2descendants
- K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017 · 2 generations on1descendant
- K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100 | Adroit Medical Systems, Inc. | 2008 | — |
| +1 | K101705 | Mistral-Air Warming System | The Surgical Company International B.V. | 2010 | 1 |
| +2 | K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017 | — |
| +3 | K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K101705 | Mistral-Air Warming System | 2010 | 2 |
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?
- Of its descendants, K101705 (The Surgical Company International B.V., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K073712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073712: Soft Air, Model SA 4000 and Mistral Air, Model MA0100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073712
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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