510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854158Substantially Equivalent

Resnick Emitter, Artificial Larynx

Dynamed Audio, Inc., Natrona Heights PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854158 is the FDA 510(k) clearance record for RESNICK EMITTER, ARTIFICIAL LARYNX, a class I device, cleared for Dynamed Audio, Inc. on under FDA product code ESE (Larynx, Artificial (Battery-Powered)). FDA records list one 510(k) clearance for Dynamed Audio, Inc. As of , FDA records show no recalls naming K854158.

Clearance record

Decision date
Received
(63 days to decision)
Product code
ESE Larynx, Artificial (Battery-Powered)
Regulation
21 CFR 874.3375
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Dynamed Audio, Inc. R.D. 1 Box 415a, Natrona Heights PA
Third party review
No

Clearances, product code ESE

Trailing 12 months

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

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