FDA product code PLA: Esophageal Thermal Regulation And Gastric Suctioning Device
PLA is the FDA product code for esophageal thermal regulation and gastric suctioning device. It is a Class II device, regulated under 21 CFR 870.5910 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under PLA, 2 in the last five years, from 5 different applicants. The average 510(k) review took 134 days (median 113); 256 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Classification
| Field | Value |
|---|---|
| Device name | Esophageal Thermal Regulation And Gastric Suctioning Device |
| Device class | Class II |
| Regulation | 21 CFR 870.5910 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PLA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 73 |
| 2018 | 3 | 90 |
| 2024 | 1 | 272 |
| 2025 | 1 | 241 |
Compare with all 510(k) review times · Search every PLA clearance
Top PLA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2 | 2018-05-17 |
| Attune Medical | 2 | 2018-01-05 |
| Advanced Cooling Therapy, LLC | 2 | 2017-03-30 |
| Arctx Medical | 1 | 2025-10-30 |
| Nuvaira, Inc. | 1 | 2024-06-27 |
Most recent PLA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250632 | Arctx Medical | Arctx Cool Catheter Set | 2025-10-30 | 241 |
| K233357 | Nuvaira, Inc. | EsoCool Thermal Regulation Catheter | 2024-06-27 | 272 |
| K180742 | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | EnsoETM | 2018-05-17 | 56 |
| K180244 | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | EnsoETM | 2018-02-28 | 30 |
| K172029 | Attune Medical | EnsoETM | 2018-01-05 | 184 |
Recalls for PLA devices
openFDA lists no recalls for product code PLA.
Frequently asked questions
What is FDA product code PLA?
PLA is the FDA product code for esophageal thermal regulation and gastric suctioning device. It is a Class II device, regulated under 21 CFR 870.5910 and reviewed by the Cardiovascular panel.
What device class is PLA?
Class II, regulation 21 CFR 870.5910. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLA?
Across 8 cleared submissions the average was 134 days from receipt to decision (median 113).
Which companies have the most PLA clearances?
Advanced Cooling Therapy, Inc. D/B/A Attune Medical (2); Attune Medical (2); Advanced Cooling Therapy, LLC (2); Arctx Medical (1); Nuvaira, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLA
- Run a recall and safety report across every PLA manufacturer
- Watch product code PLA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times