Cleared Traditional

K942189 - CRYSTAL EAR

K942189 is an FDA 510(k) clearance for CRYSTAL EAR, manufactured by Crystal Care Intl., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K942189 · Crystal Care Intl., Inc. · Ear, Nose, Throat device
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Aug 1994
Decision
97d
Days
Class 1
Risk

K942189 is an FDA 510(k) clearance for the CRYSTAL EAR. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Crystal Care Intl., Inc. (Lutz, US). The FDA issued a Cleared decision on August 9, 1994 after a review of 97 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 Crystal Care Intl., Inc. devices

FDA 510(k) Submission Details - K942189

510(k) Number K942189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date August 09, 1994
Days to Decision 97 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
8d slower than avg
Panel avg: 89d · This submission: 97d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K942189.
AUDILENS LLK
K943706 · Widex Hearing Aid Co., Inc. · Aug 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682 · Starkey Laboratories, Inc. · Aug 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · Starkey Laboratories, Inc. · Aug 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · Starkey Laboratories, Inc. · Jul 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · Starkey Laboratories, Inc. · Jun 1994
SHARP II HELIX HEARING AID
K941295 · Miracle-Ear, Inc. · Jun 1994