De Novo · Granted
GrantedEsophageal Cooling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cooling Therapy, LLC · PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Granted on Jun 23, 2015 as a new device type through De Novo after a 410-day review. 7 later devices descend from it.
- Decided
- Jun 23, 2015
- Review
- 410 days
- Class
- Class II
- Product code
- PLA
- Recalls
- None
7 later devices descend from it, 2 citing it directly.
- This deviceDEN140018 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2015
- Descendant · cites it directly · 5 of its ownK170009 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2017
- Descendant · cites it directly · 5 of its ownK152450 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK172029 EnsoETMAttune Medical · 2018
- Descendant · 2 generations on · 2 of its ownK172493 EnsoETMAttune Medical · 2017
- Descendant · 3 generations on · 1 of its ownK180244 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2017 · cites it directly5descendants
- K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2016 · cites it directly5descendants
- K172029EnsoETMAttune Medical · 2018 · 2 generations on2descendants
- K172493EnsoETMAttune Medical · 2017 · 2 generations on2descendants
- K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140018 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2015 | — |
| +1 | K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2017 | — |
| +1 | K152450 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2016 | — |
| +2 | K172029 | EnsoETM | Attune Medical | 2018 | — |
| +2 | K172493 | EnsoETM | Attune Medical | 2017 | — |
| +3 | K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170009 (Advanced Cooling Therapy, LLC, 2017) has gone furthest, with 5 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. 2015, 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?
The Esophageal Cooling Device is a thermal regulating device, intended to:
connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control
patient temperature, and
provide gastric decompression and suctioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN140018 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140018: Esophageal Cooling Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140018
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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