Cleared Traditional

K954438 - SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K954438 · Rms Div. · Anesthesiology device
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Dec 1995
Decision
95d
Days
Class 1
Risk

K954438 is an FDA 510(k) clearance for the SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Rms Div. (Palm Harbor, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 95 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 Rms Div. devices

Submission Details

510(k) Number K954438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date December 29, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 139d · This submission: 95d
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.