Cleared Traditional

K851874 - OR TUBE RESTRAINT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K851874 · Kinetic Concepts, Inc. · Anesthesiology device
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Aug 1985
Decision
101d
Days
Class 1
Risk

K851874 is an FDA 510(k) clearance for the OR TUBE RESTRAINT. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 8, 1985 after a review of 101 days - within the typical 510(k) review window.

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 Kinetic Concepts, Inc. devices

Submission Details

510(k) Number K851874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date August 08, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 139d · This submission: 101d
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.