510(k) · Cleared
Recalled · Class II · 2017Mistral-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. · DWJ System, Thermal Regulating
Cleared on Jul 2, 2010 as substantially equivalent to K073712 (Adroit Medical Systems, Inc., 2008) and 3 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 2, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K942599 (1995). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942599 Warm Air Warming UnitCincinnati Sub-Zero Products, Inc. · 1995 · Recalled
- This deviceK101705 Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010
- Descendant · cites it directly · 1 of its ownK171234 Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017
- Descendant · 2 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942599 | Warm Air Warming Unit | Cincinnati Sub-Zero Products, Inc. | 1995 | 3 |
| 0 (this device) | K101705 | Mistral-Air Warming System | The Surgical Company International B.V. | 2010 | — |
| +1 | K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100Summary page 1…P36931) Classification Name: Thermal regulating system (21 CFR 870.5900) Product Code: OWJ Predicates: * Soft-Air Patient Warming System Model SA 4000 [K073712] * Bair Hugger Model]750 Total Temperature Management System [KO0l1149] * CSZ WarmAir Hyperthermia System [K942599 and… | 2008 |
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750… | 2000 |
| * | K942599 | Warm Air Warming UnitSummary page 1…ft-Air Patient Warming System Model SA 4000 [K073712] * Bair Hugger Model]750 Total Temperature Management System [KO0l1149] * CSZ WarmAir Hyperthermia System [K942599 and K942790] Device description: The Mistral-Air Warming System comprises of the following devices: * MAI 100-US Mistral-Air P… | 1995 |
| * | K942790 | Warm Air Hypertheermia System (Models #130 and #133)Summary page 1…nt Warming System Model SA 4000 [K073712] * Bair Hugger Model]750 Total Temperature Management System [KO0l1149] * CSZ WarmAir Hyperthermia System [K942599 and K942790] Device description: The Mistral-Air Warming System comprises of the following devices: * MAI 100-US Mistral-Air Plus Warming… | 1995 |
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 |
|---|---|---|---|
| K171234 | Mistral-Air Warming Unit | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2017 | Class II | Z-0419-2018 | Component design/selection | It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K171234 (The Surgical Company International BV (As the 37company), 2017) has gone furthest, with 1 descendant 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. 2010, 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 a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101705: 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/K101705
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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