Cleared Traditional

K862768 - FACEPLATE

K862768 is the FDA 510(k) clearance for FACEPLATE by Maico Hearing Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code LRB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K862768 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Aug 1986
Decision
22d
Days
Class 1
Risk

K862768 is an FDA 510(k) clearance for the FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 13, 1986 after a review of 22 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 Maico Hearing Instruments, Inc. devices

Submission Details

510(k) Number K862768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 13, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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 - LRB Face Plate Hearing Aid

All 16
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K862768.
STARKEY MODEL P1 MODULE
K873031 · Starkey Laboratories, Inc. · Feb 1988
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
K872645 · Richards Medical Co., Inc. · Dec 1987
SERVICE MASTER (IMPULSE)
K873300 · Richards Medical Co., Inc. · Dec 1987
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR
K862769 · Maico Hearing Instruments, Inc. · Aug 1986