Cleared Traditional

K945590 - SCOPETEX(TM)

K945590 is the FDA 510(k) clearance for SCOPETEX(TM) by Smith Helms Mulliss & Moore, L.L.P.. It is a Class 1 Anesthesiology device (product code CCW) cleared through the Traditional 510(k) pathway after a 918-day FDA review.

K945590 · Smith Helms Mulliss & Moore, L.L.P. · Anesthesiology device
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May 1997
Decision
918d
Days
Class 1
Risk

K945590 is an FDA 510(k) clearance for the SCOPETEX(TM). Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Smith Helms Mulliss & Moore, L.L.P. (Greensboro, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 918 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Smith Helms Mulliss & Moore, L.L.P. devices

Submission Details

510(k) Number K945590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date May 20, 1997
Days to Decision 918 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
778d slower than avg
Panel avg: 140d · This submission: 918d
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

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