510(k) · Cleared
ClearedEsophageal 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
Cleared on Mar 30, 2017 as substantially equivalent to DEN140018 (Advanced Cooling Therapy, LLC, 2015) after an 86-day review. Its family tree reaches back 1 generation to 2015. 5 later devices descend from it.
- Decided
- Mar 30, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- PLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140018 (2015). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN140018 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2015
- This deviceK170009 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2017
- Descendant · cites it directly · 2 of its ownK172029 EnsoETMAttune Medical · 2018
- Descendant · cites it directly · 2 of its ownK172493 EnsoETMAttune Medical · 2017
- Descendant · 2 generations on · 1 of its ownK180244 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
- Descendant · 2 generations on · 0 of its ownK233357 EsoCool Thermal Regulation CatheterNuvaira, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK180742 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
Most influential descendants
Showing 5 of 5 · See all- K172029EnsoETMAttune Medical · 2018 · cites it directly2descendants
- K172493EnsoETMAttune Medical · 2017 · cites it directly2descendants
- K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018 · 2 generations on1descendant
- K233357EsoCool Thermal Regulation CatheterNuvaira, Inc. · 2024 · 2 generations on0descendants
- K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140018 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2015 | — |
| 0 (this device) | K170009 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2017 | — |
| +1 | K172029 | EnsoETM | Attune Medical | 2018 | — |
| +1 | K172493 | EnsoETM | Attune Medical | 2017 | — |
| +2 | K180244 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018 | — |
| +2 | K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | 2024 | — |
| +2 | K180742 | EnsoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | DEN140018 | Esophageal Cooling DeviceSummary page 4…1 CFR 870.5910) Product Code: PLA Class: II Predicate Device 1. Advanced Cooling Therapy, Inc. Esophageal Cooling Device (model #: ECD01-A); DEN140018 Device Description The Esophageal Cooling Device is a multi-lumen silicone tube that is placed in the esophagus in a similar ma… | 2015 |
What descends from it? (5)
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?
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. 2017, 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 or Stryker Altrix Precision Temperature Management System to control patient temperature, and
• provide gastric decompression and suctioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170009: Esophageal Cooling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170009
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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