Cleared Traditional

K921698 - CN ENDOTRACHEAL TUBE HOLDER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K921698 · N-C-N Products Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
160d
Days
Class 1
Risk

K921698 is an FDA 510(k) clearance for the CN ENDOTRACHEAL TUBE HOLDER. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by N-C-N Products Co. (Barrington, US). The FDA issued a Cleared decision on September 15, 1992 after a review of 160 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 N-C-N Products Co. devices

Submission Details

510(k) Number K921698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date September 15, 1992
Days to Decision 160 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
21d slower than avg
Panel avg: 139d · This submission: 160d
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.