510(k) · Cleared
Recalled · Class II · 2018Tecotherm Neo (T Neo)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspiration Healthcare, Ltd. · DWJ System, Thermal Regulating
Cleared on Nov 14, 2014 as substantially equivalent to K083662 (Mtre Advanced Technology, Ltd., 2009) and 2 other predicates after a 305-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.
- Decided
- Nov 14, 2014
- Review
- 305 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003349 (2000). 7 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- 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 deviceK140078 Tecotherm Neo (T Neo)Inspiration Healthcare, Ltd. · 2014
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) | K140078 | Tecotherm Neo (T Neo) | Inspiration Healthcare, Ltd. | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K083662 | CriticoolSummary page 4…ystem Classification Name: Thermal regulating system 21CFR870.5900 Product Code DWJ Predicate Devices K083662 Criticool (Primary) K071341 Arctic Sun K024128 Allon Version 5 Device Description The TECOTHERM NEO is desig… | 2009 |
| * | K071341 | Modification to Arctic Sun Temperature Management System, Model 2000Summary page 4…Thermal regulating system 21CFR870.5900 Product Code DWJ Predicate Devices K083662 Criticool (Primary) K071341 Arctic Sun K024128 Allon Version 5 Device Description The TECOTHERM NEO is designed for controlled cold & heat tre… | 2007 |
| * | K024128 | Allon 2001 Version 5Summary page 4…m 21CFR870.5900 Product Code DWJ Predicate Devices K083662 Criticool (Primary) K071341 Arctic Sun K024128 Allon Version 5 Device Description The TECOTHERM NEO is designed for controlled cold & heat treatment procedures and app… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2018 | Class II | Z-0362-2020 | Nonconforming Material/Component | The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer be able to guarantee temperature… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 6 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083662.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient’s temperature through conductive heat transfer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140078: Tecotherm Neo (T Neo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140078
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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