Cleared Traditional

CRAIGWELL MASTER HEARING AID MHA (K854126) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854126 · Craigwell Electronics, Ltd. · Ear, Nose, Throat device
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Jan 1986
Decision
99d
Days
Class 2
Risk

K854126 is an FDA 510(k) clearance for the CRAIGWELL MASTER HEARING AID MHA. Classified as Hearing Aid, Master (product code KHL), 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 874.3330 - 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

Submission Details

510(k) Number K854126 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.

Device Classification

Product Code KHL Hearing Aid, Master
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3330
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.