Cleared Traditional

K913592 - QUALITONE 46PP-AGC-I

K913592 is the FDA 510(k) clearance for QUALITONE 46PP-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 37-day FDA review.

K913592 · Qualitone · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
37d
Days
Class 1
Risk

K913592 is an FDA 510(k) clearance for the QUALITONE 46PP-AGC-I. 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 37 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 K913592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date September 18, 1991
Days to Decision 37 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
52d faster than avg
Panel avg: 89d · This submission: 37d
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 K913592.
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
UC312, ULTRA MINIATURE ITC HEARING AID
K914017 · 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
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
K913502 · Phonak, Inc. · Sep 1991