510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K854356Substantially Equivalent

Stethoscope Electronic Stethoscope Sphygmomanomete

Fontaine Industries, Inc., Long Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854356 is the FDA 510(k) clearance record for STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE, a class II device, cleared for Fontaine Industries, Inc. on under FDA product code DQD (Stethoscope, Electronic). FDA records list one 510(k) clearance for Fontaine Industries, Inc. As of , FDA records show no recalls naming K854356.

Clearance record

Decision date
Received
(188 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Fontaine Industries, Inc. P.O. Box 92612, Long Beach CA
Third party review
No

Clearances, product code DQD

Trailing 12 months
6 clearances under product code DQD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DQD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20262
August 20260
September 20260
October 20260