510(k) · Cleared
ClearedEsoCool Thermal Regulation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvaira, Inc. · PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Cleared on Jun 27, 2024 as substantially equivalent to K172493 (Attune Medical, 2017) after a 272-day review. Its family tree reaches back 3 generations to 2015.
- Decided
- Jun 27, 2024
- Review
- 272 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. No later device cites it as a predicate yet.
- Root · 3 generations backDEN140018 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2015
- 2 generations backK152450 Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC · 2016
- 1 generation backK172493 EnsoETMAttune Medical · 2017
- This deviceK233357 EsoCool Thermal Regulation CatheterNuvaira, Inc. · 2024
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 | K172493 | EnsoETM | Attune Medical | 2017 | — |
| 0 (this device) | K233357 | EsoCool Thermal Regulation Catheter | Nuvaira, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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
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 |
|---|---|---|---|
| * | K172493 | EnsoETMSummary page 4…ophageal thermal regulation device Regulation Number: 870.5910 Product Code: PLA Legally Marketed Predicate Devices Predicate Number: K172493 Predicate Trade Name: EnsoETM Predicate Product Code: PLA Device Description Summary: The EsoCool Thermal Regulation… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K172493.
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. 2024, 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 EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233357: EsoCool Thermal Regulation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233357
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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