510(k) · Cleared
Recalled · Class II · 2026Blanketrol II Hyper-Hypothermia Temperature Managment System
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 Feb 4, 2011 as substantially equivalent to K101589 (Cincinnati Sub-Zero Products, Inc., 2010) after a 22-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Feb 4, 2011
- Review
- 22 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003349 (2000). 8 ancestors in all, the oldest K811742 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
- 3 generations backK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
- 2 generations backK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- 1 generation backK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- This deviceK110104 Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK121720 Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | 2000 | — |
| −3 | K024128 | Allon 2001 Version 5 | Mtre Advanced Technology, Ltd. | 2003 | 1 |
| −2 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| −1 | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | Cincinnati Sub-Zero Products, Inc. | 2010 | 6 |
| 0 (this device) | K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment System | Cincinnati Sub-Zero Products, Inc. | 2011 | — |
| +1 | K121720 | Welkins Emt/Icu Temperature Managerment System | Welkins, LLC | 2012 | — |
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 |
|---|---|---|
| 2012 | 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? (1)
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 |
|---|---|---|---|
| * | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsSummary page 1…11. IDENTIFICATION OF PREDICATES: a. Cincinnati Sub-Zero Blanketrol III Model 233 Hyper-Hypothermia Temperature Management System (K 10 15 89) DEVICE DESCRIPTION The Blanketrol II Model 222S is a water (liquid) recirculating device providing either… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121720 | Welkins Emt/Icu Temperature Managerment System | 2012 | 0 |
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-2968-2026 | 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-0418-2020 | 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 |
| Jan 8, 2014 | Class II | Z-1679-2014 | Mixed-up of materials/components | The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 8 ancestors have a recall of any class.
- Of its descendants, K121720 (Welkins, LLC, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101589.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 II Model 222S Hyper-Hypothermia Temperature Management System is 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/K110104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110104
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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