510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180244Substantially Equivalent

EnsoETM

Advanced Cooling Therapy, Inc. D/B/A Attune Medical, Chicago IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180244 is the FDA 510(k) clearance record for EnsoETM, a class II device, cleared for Advanced Cooling Therapy, Inc. D/B/A Attune Medical on under FDA product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device). FDA's definition for product code PLA reads: "The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage". FDA records list 3 510(k) clearances for Advanced Cooling Therapy, Inc. D/B/A Attune Medical, from to . As of , FDA records show no recalls naming K180244.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Regulation
21 CFR 870.5910
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cooling Therapy, Inc. D/B/A Attune Medical 3440 S. Dearborn St., Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLA

Trailing 12 months

FDA records hold no clearances under product code PLA in the trailing twelve months.

FDA records show no clearances under product code PLA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260