510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894019Substantially Equivalent

Resound Demo. Behind-the-Ear Hrng., Model Demo Bte

Resound Corp., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894019 is the FDA 510(k) clearance record for RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE, a class II device, cleared for Resound Corp. on under FDA product code KHL (Hearing Aid, Master). FDA records list 41 510(k) clearances for Resound Corp., from to . As of , FDA records show no recalls naming K894019.

Clearance record

Decision date
Received
(107 days to decision)
Product code
KHL Hearing Aid, Master
Regulation
21 CFR 874.3330
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Resound Corp. 220 Saginaw Dr.,, Redwood City CA
Third party review
No

Clearances, product code KHL

Trailing 12 months

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

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