510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914887Substantially Equivalent

Esophageal Stethoscope W/temp Sensor/gastric Suct

Mallinckrodt Medical, St Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914887 is the FDA 510(k) clearance record for ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT, a class II device, cleared for Mallinckrodt Medical on under FDA product code FRQ (Tube, Levine). FDA records list 43 510(k) clearances for Mallinckrodt Medical, from to . As of , FDA records show no recalls naming K914887.

Clearance record

Decision date
Received
(191 days to decision)
Product code
FRQ Tube, Levine
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mallinckrodt Medical 675 Mcdonnell Blvd. P.O. Box, St Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code FRQ

Trailing 12 months

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

FDA records show no clearances under product code FRQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRQ, 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