510(k) · Cleared
ClearedEnsoETM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Attune Medical · PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Cleared on Oct 17, 2017 as substantially equivalent to K170009 (Advanced Cooling Therapy, LLC, 2017) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2015. 2 later devices descend from it.
- Decided
- Oct 17, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- PLA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN140018 (2015). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN140018 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2015
- 1 generation backK152450 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2016
- This deviceK172493 EnsoETMAttune Medical · 2017
- Descendant · cites it directly · 0 of its ownK233357 EsoCool Thermal Regulation CatheterNuvaira, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK180742 EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN140018 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2015 | — |
| −1 | K152450 | Esophageal Cooling Device | Advanced Cooling Therapy, LLC | 2016 | — |
| 0 (this device) | K172493 | EnsoETM | Attune Medical | 2017 | — |
| +1 | K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | 2024 | — |
| +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 |
| 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? (2)
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 |
|---|---|---|---|
| * | K170009 | Esophageal Cooling DeviceSummary page 4…Classification Name: Esophageal Thermal Regulation Device (21 CFR 870.5910) Product Code: PLA Class: 1] Predicate Device 1. Attune Medical EnsoETM (model #: ECD01-A); K170009 2. Attune Medical EnsoETM (model #: ECD02-A); K152450 Device Description The EnsoETM is a multi-lumen silicone tube that is pla… | 2017 |
| * | K152450 | Esophageal Cooling DeviceSummary page 4…ice (21 CFR 870.5910) Product Code: PLA Class: 1] Predicate Device 1. Attune Medical EnsoETM (model #: ECD01-A); K170009 2. Attune Medical EnsoETM (model #: ECD02-A); K152450 Device Description The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard… | 2016 |
What descends from it? (2)
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233357 (Nuvaira, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170009.
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?
Model #ECD01-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,
• and provide gastric decompression and suctioning.
Model # ECD02-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,
• 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/K172493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172493: EnsoETM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172493
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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