Cleared Traditional

K941636 - MINI PAK

K941636 is the FDA 510(k) clearance for MINI PAK by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K941636 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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May 1994
Decision
30d
Days
Class 1
Risk

K941636 is an FDA 510(k) clearance for the MINI PAK. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 30 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K941636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date May 04, 1994
Days to Decision 30 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
59d faster than avg
Panel avg: 89d · This submission: 30d
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 400
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K941636.
STARKEY EUROLINE A SERIES
K940978 · Starkey Laboratories, Inc. · May 1994
WIDEX S-21
K941508 · Widex Hearing Aid Co., Inc. · May 1994
INTRA S, INTRA SH
K941635 · Starkey Laboratories, Inc. · May 1994
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD
K935867 · Unitron Industries, Inc. · Mar 1994
AIR CONDUCTION HEARING AID: IKON PP
K936106 · Unitron Industries, Inc. · Mar 1994
MIRACLE-EAR CONFIDANTE
K940458 · Miracle-Ear, Inc. · Mar 1994