Cleared Traditional

K831981 - LARYNGESCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K831981 · W.E. Leder Enterprises, Inc. · Anesthesiology device
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Sep 1983
Decision
101d
Days
Class 1
Risk

K831981 is an FDA 510(k) clearance for the LARYNGESCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by W.E. Leder Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all W.E. Leder Enterprises, Inc. devices

Submission Details

510(k) Number K831981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date September 29, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 139d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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.