Cleared Traditional

K901489 - MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K901489 · Eastmed Enterprises, Inc. · Anesthesiology device
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Apr 1990
Decision
12d
Days
Class 1
Risk

K901489 is an FDA 510(k) clearance for the MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE). 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 April 10, 1990 after a review of 12 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 Eastmed Enterprises, Inc. devices

Submission Details

510(k) Number K901489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date April 10, 1990
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 139d · This submission: 12d
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.