Cleared Traditional

K841778 - D.L. SCOPE BLADE & HANDLE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K841778 · North American Medical Products, Inc. · Anesthesiology device
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May 1984
Decision
23d
Days
Class 1
Risk

K841778 is an FDA 510(k) clearance for the D.L. SCOPE BLADE & HANDLE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by North American Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 23 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 North American Medical Products, Inc. devices

Submission Details

510(k) Number K841778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1984
Decision Date May 23, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 139d · This submission: 23d
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.