510(k) · Cleared
Recalled · Class II · 2026Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems
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 Sep 20, 2010 as substantially equivalent to K912051 (Gaymar Industries, Inc., 1991) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 20, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003349 (2000). 7 ancestors in all, the oldest K811742 (1981). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
- 2 generations backK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
- 1 generation backK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- This deviceK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110104 Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK122813 Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK121720 Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012
- Descendant · cites it directly · 0 of its ownK120081 Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 2011 · cites it directly1descendant
- K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc. · 2012 · cites it directly0descendants
- K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012 · 2 generations on0descendants
- K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | 2000 | — |
| −2 | K024128 | Allon 2001 Version 5 | Mtre Advanced Technology, Ltd. | 2003 | 1 |
| −1 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| 0 (this device) | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | Cincinnati Sub-Zero Products, Inc. | 2010 | — |
| +1 | K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment System | Cincinnati Sub-Zero Products, Inc. | 2011 | 3 |
| +1 | K122813 | Hemotherm Model 400CE Cooler/Heater System | Cincinnati Sub-Zero Products, Inc. | 2012 | 6 |
| +2 | K121720 | Welkins Emt/Icu Temperature Managerment System | Welkins, LLC | 2012 | — |
| +1 | K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/Pads | Cincinnati Sub-Zero Products, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K912051 | Medi-Therm (Mta-5900) & Detachable HosesSummary page 1…Hyper-Hypothermia System, Model 200 (pre-amendment device) b. Gaymar Industries MediTherm II Series 5900 Hyper/Hypothermia System (K912051) c. M.T.R.E Advanced Technology Ltd. CritiCool device (K083662) Submission Page: 1… | 1991 |
| * | K083662 | CriticoolSummary page 1…b. Gaymar Industries MediTherm II Series 5900 Hyper/Hypothermia System (K912051) c. M.T.R.E Advanced Technology Ltd. CritiCool device (K083662) Submission Page: 17 Cincinnati Sub-Zero, Inc. 5 10(k) Premarket Notification… | 2009 |
| * | — | Cincinnati Sub-Zero Blanketrol Hyper-Hypothermia System, Model 200 Named without a submission number |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2026 | Class II | Z-2969-2026 | Device Design | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. |
| Jul 13, 2026 | Class II | Z-2970-2026 | Device Design | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down, |
| Jul 2, 2019 | Class II | Z-0419-2020 | Labeling False and Misleading | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes |
| Jul 2, 2019 | Class II | Z-0417-2020 | Labeling False and Misleading | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes |
| Sep 3, 2013 | Class II | Z-2209-2013 | Labeling Change Control | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously… |
| Oct 18, 2010 | Not classified | Z-1817-2011 | Other | The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K110104 (Cincinnati Sub-Zero Products, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K912051.
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 Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101589
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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