Cleared Traditional

K791310 - DAHLBERG HEARING AID MODEL GC

K791310 is an FDA 510(k) clearance for DAHLBERG HEARING AID MODEL GC, manufactured by Dahlberg Electronics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K791310 · Dahlberg Electronics, Inc. · Ear, Nose, Throat device
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Sep 1979
Decision
74d
Days
Class 1
Risk

K791310 is an FDA 510(k) clearance for the DAHLBERG HEARING AID MODEL GC. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Dahlberg Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1979 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dahlberg Electronics, Inc. devices

FDA 510(k) Submission Details - K791310

510(k) Number K791310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1979
Decision Date September 28, 1979
Days to Decision 74 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 89d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K791310.
RIONET HEARING AID HB-67T
K791882 · Rion Acoustic Instruments, Inc. · Oct 1979
RIONET HEARING AID HI-60
K791884 · Rion Acoustic Instruments, Inc. · Oct 1979
RIONET HEARING AID HB-64S
K791879 · Rion Acoustic Instruments, Inc. · Oct 1979
MODEL 33DA HEARING AIDS
K791599 · Telex Communications, Inc. · Sep 1979
MODEL 33A HEARING AIDS
K791600 · Telex Communications, Inc. · Sep 1979
MODEL 336A HEARING AIDS
K791601 · Telex Communications, Inc. · Sep 1979