Cleared Traditional

K843790 - TRACHEAL TUBE FIXATION DEVICE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K843790 · Laerdal California, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
165d
Days
Class 1
Risk

K843790 is an FDA 510(k) clearance for the TRACHEAL TUBE FIXATION DEVICE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Laerdal California, Inc. (Long Beach, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 165 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 Laerdal California, Inc. devices

Submission Details

510(k) Number K843790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date March 11, 1985
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 139d · This submission: 165d
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.