510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925789Substantially Equivalent

Debusk Temp. Syst. Esophageal Stethoscope

DeRoyal Industries, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925789 is the FDA 510(k) clearance record for DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE, a class II device, cleared for Deroyal Industries, Inc. on under FDA product code BZT (Stethoscope, Esophageal, With Electrical Conductors). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K925789.

Clearance record

Decision date
Received
(239 days to decision)
Product code
BZT Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
Device class
Class II
Review panel
Anesthesiology
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
510(k) summary
Statement
Third party review
No

Clearances, product code BZT

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