Cleared Traditional

K914017 - UC312

K914017 is the FDA 510(k) clearance for UC312 by Qualitone. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K914017 · Qualitone · Ear, Nose, Throat device

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Sep 1991

Decision

14d

Days

Class 1

Risk

K914017 is an FDA 510(k) clearance for the UC312, ULTRA MINIATURE ITC 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 23, 1991 after a review of 14 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	K914017 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 09, 1991
Decision Date	September 23, 1991
Days to Decision	14 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

75d faster than avg

Panel avg: 89d · This submission: 14d

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 K914017.

AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID

K914477 · Miracle-Ear, Inc. · Oct 1991

MODEL 80 HEARING AID DISPENSING SYSTEM

K913245 · 3M Company · Oct 1991

SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION

K914333 · Siemens Hearing Instruments, Inc. · Oct 1991

QUALITONE 46PP-AGC-I

K913592 · Qualitone · Sep 1991

ELEGANCE - KED, BEHIND THE EAR HEARING AID

K913771 · Qualitone · Sep 1991

QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID

K913781 · Qualitone · Sep 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 K914017

Qualitone

Minneapolis, MN · US

BRUCE A 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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