Cleared Traditional

K913781 - QUALITONE 48PP-AGC-I

K913781 is the FDA 510(k) clearance for QUALITONE 48PP-AGC-I by Qualitone. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K913781 · Qualitone · Ear, Nose, Throat device

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Sep 1991

Decision

34d

Days

Class 1

Risk

K913781 is an FDA 510(k) clearance for the QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Qualitone (Minneapolis, US). The FDA issued a Cleared decision on September 18, 1991 after a review of 34 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 Qualitone devices

Submission Details

510(k) Number	K913781 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 1991
Decision Date	September 18, 1991
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

55d faster than avg

Panel avg: 89d · This submission: 34d

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 739

Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K913781.

UC312, ULTRA MINIATURE ITC HEARING AID

K914017 · Qualitone · Sep 1991

QUALITONE 46PP-AGC-I

K913592 · Qualitone · Sep 1991

ELEGANCE - KED, BEHIND THE EAR HEARING AID

K913771 · Qualitone · Sep 1991

PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT

K913502 · Phonak, Inc. · Sep 1991

PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT

K913503 · Phonak, Inc. · Sep 1991

HEARING AID, UNITRON MODEL UIK

K912870 · Unitron Industries, Inc. · Jul 1991

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K913781

Qualitone

Minneapolis, MN · US

BRUCE BROWN

Regulatory profile

39 submissions 39 cleared

100% clearance rate · Active in Ear, Nose, Throat

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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