Cleared Traditional

K974751 - TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC

K974751 is an FDA 510(k) clearance for TRANQUIL TRI-OE, manufactured by General Hearing Instruments, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K974751 · General Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
77d
Days
Class 1
Risk

K974751 is an FDA 510(k) clearance for the TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by General Hearing Instruments, Inc. (Harahan, US). The FDA issued a Cleared decision on March 6, 1998 after a review of 77 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 General Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K974751

510(k) Number K974751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date March 06, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 90d · This submission: 77d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K974751.
LYRIC HEARING AID
K081136 · Insound Medical, Inc. · May 2008
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · Siemens Hearing Instruments, Inc. · Apr 2001
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518 · Sonic Innovations, Inc. · Mar 1999
ARGOSY PROGRAMMABLE ONQUE
K974242 · Argosy Electronics · Jan 1998
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
K973880 · Sonix Technologies, Inc. · Jan 1998
OPUS 2 - CANAL SERIES (ITC)
K974069 · Bernafon-Maico, Inc. · Dec 1997