Cleared Traditional

K861026 - LIBAN INTUBATOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K861026 · Life Support Devices Co. · Anesthesiology device
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Jul 1986
Decision
132d
Days
Class 1
Risk

K861026 is an FDA 510(k) clearance for the LIBAN INTUBATOR. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Life Support Devices Co. (Marina Del Rey, US). The FDA issued a Cleared decision on July 28, 1986 after a review of 132 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 Life Support Devices Co. devices

Submission Details

510(k) Number K861026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date July 28, 1986
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 139d · This submission: 132d
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.