510(k) · Cleared
ClearedEnsoETM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cooling Therapy, Inc. D/B/A Attune Medical · PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Cleared on Feb 28, 2018 as substantially equivalent to K172029 (Attune Medical, 2018) after a 30-day review. Its family tree reaches back 3 generations to 2015. 1 later device descends from it.
- Decided
- Feb 28, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- PLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN140018 (2015). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN140018 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2015
- 2 generations backK152450 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2016
- 1 generation backK172029 EnsoETMAttune Medical · 2018
- This deviceK180244 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
- Descendant · cites it directly · 0 of its ownK180742 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN140018 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2015 | — |
| −2 | K152450 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2016 | — |
| −1 | K172029 | EnsoETM | Attune Medical | 2018 | — |
| 0 (this device) | K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018 | — |
| +1 | K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 PLA? 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 PLA device
- #1 K250632 Arctx Cool Catheter Setscore 10.9 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K172029 | EnsoETMSummary page 4…ation Name: Esophageal Thermal Regulation Device (21 CFR 870.5910) Product Code: PLA Class: 1] Predicate Devices Attune Medical EnsoETM (model #s: ECD03-A & ECD04-A); K172029 Reference Devices Attune Medical EnsoETM (model #s: ECD01-A & ECD02-A); K172493 Device Description The EnsoETM is a multi-lum… | 2018 |
| † | K172493 | EnsoETM | 2017 |
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 |
|---|---|---|---|
| K180742 | EnsoETM | 2018 | 0 |
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 3 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180742 (Advanced Cooling Therapy, Inc. D/B/A Attune Medical, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PLA devicesPLA Esophageal Thermal Regulation And Gastric Suctioning Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PLA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLA
56in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLA
No recall names PLA since 2007.
Adverse event reports per year · PLA
2in 2024
MAUDE reports naming product code PLA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 3 |
| 2018 | 3 | 56 | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Model # ECD03-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.
Model # ECD04-A:
The EnsoETM is a thermal regulating device, intended to:
• connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature,
• allow enteral administration of fluids,
• and provide gastric decompression and suctioning.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180244: EnsoETM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180244
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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