Cleared Traditional

K854125 - CRAIGWELL AID FITTING SYSTEM AFS

K854125 is an FDA 510(k) clearance for CRAIGWELL AID FITTING SYSTEM AFS, manufactured by Craigwell Electronics, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854125 · Craigwell Electronics, Ltd. · Ear, Nose, Throat device
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Jan 1986
Decision
99d
Days
Class 2
Risk

K854125 is an FDA 510(k) clearance for the CRAIGWELL AID FITTING SYSTEM AFS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Craigwell Electronics, Ltd. (Wiltshire Sn2 4bj, GB). The FDA issued a Cleared decision on January 16, 1986 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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 Craigwell Electronics, Ltd. devices

FDA 510(k) Submission Details - K854125

510(k) Number K854125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1985
Decision Date January 16, 1986
Days to Decision 99 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 89d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K854125.
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · Resound Corp. · Feb 1989
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
AUDIOMETER/MASTER HEARING AID MF6
K862770 · Maico Hearing Instruments, Inc. · Aug 1986
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981