Cleared Traditional

K941635 - INTRA S, INTRA SH

K941635 is an FDA 510(k) clearance for INTRA S, manufactured by Starkey Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K941635 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
30d
Days
Class 1
Risk

K941635 is an FDA 510(k) clearance for the INTRA S, INTRA SH. 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

FDA 510(k) Submission Details - K941635

510(k) Number K941635 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
60d faster than avg
Panel avg: 90d · This submission: 30d
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 951
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K941635.
RIONET HEARING AID HB-37T
K941140 · Authorized Hearing Systems, Inc. · May 1994
BELTON MERIT (HEARING AID)
K941395 · Beltone Electronics Corp. · May 1994
WIDEX S-21
K941508 · Widex Hearing Aid Co., Inc. · May 1994
MINI PAK
K941636 · Starkey Laboratories, Inc. · May 1994
COMPLETELY IN THE CANAL
K940116 · Argosy Electronics · May 1994
OTOSONIC (OSI) LPS D
K940099 · Beltone Electronics Corp. · Apr 1994