510(k) · Cleared
ClearedWarmair Model 135 Hyperthermia System Including Filteredflo Blankets
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 17, 2013 as substantially equivalent to K101148 (Cincinnati Sub-Zero Products, Inc., 2010) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jan 17, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904690 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK904690 Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 1991
- 3 generations backK011907 Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc. · 2001 · Recalled
- 2 generations backK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- 1 generation backK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
- This deviceK123946 Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904690 | Temp Marq (TM) Convective Warming System | Marquest Medical Products, Inc. | 1991 | — |
| −3 | K011907 | Snuggle Warm 4000 Convective Warming System | Sims Level 1, Inc. | 2001 | 1 |
| −2 | K101148 | Warm Air Model 135 Hyperthermia System and Blankets | Cincinnati Sub-Zero Products, Inc. | 2010 | 2 |
| −1 | K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets) | Cincinnati Sub-Zero Products, Inc. | 2012 | — |
| 0 (this device) | K123946 | Warmair Model 135 Hyperthermia System Including Filteredflo Blankets | Cincinnati Sub-Zero Products, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K101148 | Warm Air Model 135 Hyperthermia System and BlanketsSummary page 2…et differs in size from other blankets and is placed under the body of the patient in the same manner as the neonate/pediatric FilteredFlo® blanket previously cleared in K101 148. There is no change to the intended use statement. INTENDED USE The WarmiAir 135 patient warming system is intended to prevent h… | 2010 |
| * | K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets)Summary page 1…smetic Act 11. IDENTIFICATION OF PREDICATE: a. WarmAir®D Model 135 Hyperthermia System including blankets (KI10 1148 and K1 21669) DEVICE DESCRIPTION The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air war… | 2012 |
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 8.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K101148.
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 WarmAir®D 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123946: Warmair Model 135 Hyperthermia System Including Filteredflo Blankets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123946
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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