Cleared Traditional

K831981 - LARYNGESCOPE

K831981 is an FDA 510(k) clearance for LARYNGESCOPE, manufactured by W.E. Leder Enterprises, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K831981

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
39d faster than avg
Panel avg: 140d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

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.

Regulatory Peers - CCW Laryngoscope, Rigid

All 29
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K831981.
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
K882930 · Pilling Co. · Aug 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · Augustine Medical, Inc. · Jul 1988
LARYNGOSCOPE BLADES/HANDLES & LAMPS
K833055 · Medovations, Inc. · Nov 1983
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980