Cleared Traditional

K923648 - LECTRO-LARYNX

K923648 is an FDA 510(k) clearance for LECTRO-LARYNX, manufactured by Bruce Medical Supply. The device is a Class 1 Ear, Nose, Throat device with product code ESE cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K923648 · Bruce Medical Supply · Ear, Nose, Throat device
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Apr 1993
Decision
260d
Days
Class 1
Risk

K923648 is an FDA 510(k) clearance for the LECTRO-LARYNX. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Bruce Medical Supply (Waltham, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 260 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3375 - 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 Bruce Medical Supply devices

FDA 510(k) Submission Details - K923648

510(k) Number K923648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date April 07, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 89d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

ESE Device Classification - Class 1, General Controls

Product Code ESE Larynx, Artificial (battery-powered)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3375
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.