Cleared Traditional

K831981 - LARYNGESCOPE

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

K831981 · W.E. Leder Enterprises, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
39d faster than avg
Panel avg: 140d · 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.

Regulatory Peers - CCW Laryngoscope, Rigid

Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K831981.
APA Oxy Blade
K191602 · Venner Medical (Singapore) Pte, Ltd. · Aug 2019
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
K951804 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980