Cleared Traditional

K914741 - AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED (FDA 510(k) Clearance)

Class I Anesthesiology device.

K914741 · Eastmed Enterprises, Inc. · Anesthesiology device
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Feb 1992
Decision
108d
Days
Class 1
Risk

K914741 is an FDA 510(k) clearance for the AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on February 3, 1992 after a review of 108 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 Eastmed Enterprises, Inc. devices

Submission Details

510(k) Number K914741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date February 03, 1992
Days to Decision 108 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
31d faster than avg
Panel avg: 139d · This submission: 108d
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.