FDA product code · Cardiovascular
Esophageal Thermal Regulation And Gastric Suctioning Device
9 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 257 days (half between 249 and 264). No recall names this code. The most-cited predicate is K170009, named by 2 later devices.
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PLA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in PLA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report