Cleared Traditional

K954922 - REXTON'S HORIZION FAMILY OF MULTIPLE SI...

K954922 is an FDA 510(k) clearance for REXTON'S HORIZION FAMILY OF MULTIPLE SI..., manufactured by Rexton, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954922 · Rexton, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
83d
Days
Class 1
Risk

K954922 is an FDA 510(k) clearance for the REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE I.... Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Rexton, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 83 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 Rexton, Inc. devices

FDA 510(k) Submission Details - K954922

510(k) Number K954922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1995
Decision Date January 17, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 89d · This submission: 83d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K954922.
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · Widex Hearing Aid Co., Inc. · Feb 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867 · Resound Corp. · Feb 1996
MIRACLE EAR MIRAGE
K954119 · Miracle-Ear, Inc. · Jan 1996
MIRACLE EAR AND AUDIOTONE
K954941 · Miracle-Ear, Inc. · Dec 1995
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI
K955574 · Resound Corp. · Dec 1995
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · Qualitone · Dec 1995