510(k) · Cleared
ClearedWarm Air Hypertheermia System (Models #130 and #133)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cincinnati Sub-Zero Products, Inc. · DWJ System, Thermal Regulating
Cleared on Jan 24, 1995 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 24, 1995
- Review
- 225 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK942790 Warm Air Hypertheermia System (Models #130 and #133)Cincinnati Sub-Zero Products, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- 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 · 2 generations on · 1 of its ownK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK261437 Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · cites it directly2descendants
- 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
- K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012 · 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) | K942790 | Warm Air Hypertheermia System (Models #130 and #133) | Cincinnati Sub-Zero Products, Inc. | 1995 | — |
| +1 | K101148 | Warm Air Model 135 Hyperthermia System and Blankets | Cincinnati Sub-Zero Products, Inc. | 2010 | 2 |
| +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 | — |
| +2 | K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets) | Cincinnati Sub-Zero Products, Inc. | 2012 | — |
| +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 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K101148 (Cincinnati Sub-Zero Products, Inc., 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.
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 | — |
https://510kreport.com/device/K942790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942790: Warm Air Hypertheermia System (Models #130 and #133).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942790
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026