Cleared Traditional

K953179 - CLM LARYNGOSCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K953179 · Penlon , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
88d
Days
Class 1
Risk

K953179 is an FDA 510(k) clearance for the CLM LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Penlon , Ltd. (Oxonn, GB). The FDA issued a Cleared decision on October 6, 1995 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Penlon , Ltd. devices

Submission Details

510(k) Number K953179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date October 06, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 139d · This submission: 88d
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.