Cleared Traditional

K864526 - ENDOTRACHEAL TUBE HOLDER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K864526 · Mathew Medical Co. · Anesthesiology device
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May 1987
Decision
185d
Days
Class 1
Risk

K864526 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE HOLDER. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Mathew Medical Co. (Phoenix, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 185 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Mathew Medical Co. devices

Submission Details

510(k) Number K864526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date May 21, 1987
Days to Decision 185 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 139d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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.