Cleared Traditional

K915076 - MED-EQUIP CORPORATION

K915076 is the FDA 510(k) clearance for MED-EQUIP CORPORATION by Medequip Co.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K915076 · Medequip Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
62d
Days
Class 1
Risk

K915076 is an FDA 510(k) clearance for the MED-EQUIP CORPORATION. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Medequip Co. (Honolulu, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 62 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 Medequip Co. devices

Submission Details

510(k) Number K915076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date January 09, 1992
Days to Decision 62 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
27d faster than avg
Panel avg: 89d · This submission: 62d
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 226
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K915076.
PREMIER K-AMP
K914799 · Electone, Inc. · Feb 1992
AM 300 XP
K914947 · Electone, Inc. · Feb 1992
AUDIOTONE MODEL A-96
K920093 · Miracle-Ear, Inc. · Jan 1992
HEARING AID, UNITRON MODEL VISTA 3000
K914688 · Unitron Industries, Inc. · Nov 1991
HEARING AID, UNITRON MODEL VISTA 4000
K914689 · Unitron Industries, Inc. · Nov 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477 · Miracle-Ear, Inc. · Oct 1991