Cleared Traditional

K942529 - HCI TUBE STABILIZER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K942529 · Health Care Contracts, Inc. · Anesthesiology device
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Jun 1995
Decision
383d
Days
Class 1
Risk

K942529 is an FDA 510(k) clearance for the HCI TUBE STABILIZER. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Health Care Contracts, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K942529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1994
Decision Date June 14, 1995
Days to Decision 383 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 139d · This submission: 383d
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.