Cleared Traditional

K915161 - AUGUSTINE FIBEROPTIC LARYNGOSCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K915161 · Augustine Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
197d
Days
Class 1
Risk

K915161 is an FDA 510(k) clearance for the AUGUSTINE FIBEROPTIC LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 197 days - an extended review 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: 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 Augustine Medical, Inc. devices

Submission Details

510(k) Number K915161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1991
Decision Date May 29, 1992
Days to Decision 197 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
58d slower than avg
Panel avg: 139d · This submission: 197d
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.