510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811862Substantially Equivalent

Hi-Lo Temp Esophageal Stethoscope

Mallinckrodt Critical Care, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811862 is the FDA 510(k) clearance record for HI-LO TEMP ESOPHAGEAL STETHOSCOPE, a class II device, cleared for Mallinckrodt Critical Care on under FDA product code BZT (Stethoscope, Esophageal, With Electrical Conductors). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K811862.

Clearance record

Decision date
Received
(9 days to decision)
Product code
BZT Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt Critical Care 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BZT

Trailing 12 months
1 clearance under product code BZT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260