Cleared Traditional

K790482 - MODEL 4107-2S

K790482 is the FDA 510(k) clearance for MODEL 4107-2S by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K790482 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Apr 1979
Decision
26d
Days
Class 1
Risk

K790482 is an FDA 510(k) clearance for the MODEL 4107-2S, HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 26 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K790482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1979
Decision Date April 03, 1979
Days to Decision 26 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
63d faster than avg
Panel avg: 89d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 400
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K790482.
MODEL SE-1 EYEGLASS HEARING AID
K791203 · Starkey Laboratories, Inc. · Aug 1979
_MODEL WC-1 BEHIND-THE-EAR HEARING AID
K790745 · Starkey Laboratories, Inc. · May 1979
MODEL WC-3 HEARING AID
K790651 · Starkey Laboratories, Inc. · Apr 1979
HEARING AID, OTICON I II H
K790301 · Oticon Corp. · Feb 1979
EARETTE HEARING AID
K790228 · Oticon Corp. · Feb 1979
HEARING AID, ITE MODULAR MODEL I, II, V
K781663 · Oticon Corp. · Oct 1978