Cleared Traditional

K931040 - MT 80 SP

K931040 is an FDA 510(k) clearance for MT 80 SP, manufactured by Maico 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 92-day FDA review.

K931040 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Jun 1993
Decision
92d
Days
Class 1
Risk

K931040 is an FDA 510(k) clearance for the MT 80 SP. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Maico Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K931040

510(k) Number K931040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date June 01, 1993
Days to Decision 92 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
2d slower than avg
Panel avg: 90d · This submission: 92d
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 K931040.
M30 IN THE EAR HEARING AID
K922501 · Electone, Inc. · Jun 1993
M32 IN THE EAR HEARING AID
K922502 · Electone, Inc. · Jun 1993
MODELS 33PP, 33PP ANR, & 33PP SUPER HEARING AID
K931035 · Maico Hearing Instruments, Inc. · Jun 1993
STAR 42 PP-SP, STAR 42 PP-SL (T100)
K931041 · Maico Hearing Instruments, Inc. · Jun 1993
SERIES STAR 66 BEKHIND THE EAR HEARING AID
K931160 · Maico Hearing Instruments, Inc. · Jun 1993
SERIES STAR 22 - BEHIND THE EAR HEARING AID
K931161 · Maico Hearing Instruments, Inc. · Jun 1993