Cleared Traditional

K864526 - ENDOTRACHEAL TUBE HOLDER

K864526 is an FDA 510(k) clearance for ENDOTRACHEAL TUBE HOLDER, manufactured by Mathew Medical Co.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

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.

FDA 510(k) Submission Details - K864526

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
45d slower than avg
Panel avg: 140d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

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.

Regulatory Peers - CBH Device, Fixation, Tracheal Tube

All 38
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K864526.
RESPIRONIC'S INFANT SECUREEASY
K882079 · Respironics, Inc. · Aug 1988
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
K872277 · Ackrad Laboratories · Jul 1987
BABY E.T. TAPE(TM)
K871560 · B&B Medical Technologies, Inc. · May 1987
E. T. TAPE ENDOTRACHEAL TUBE HOLDER
K862084 · B&B Medical Technologies, Inc. · Jun 1986
RESPIRONICS SECUREASY
K860845 · Respironics, Inc. · Mar 1986
OR TUBE RESTRAINT
K851874 · Kinetic Concepts, Inc. · Aug 1985
K864526 · ENDOTRACHEAL TUBE HOLDER
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