Cleared Traditional

K843790 - TRACHEAL TUBE FIXATION DEVICE

K843790 is an FDA 510(k) clearance for TRACHEAL TUBE FIXATION DEVICE, manufactured by Laerdal California, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K843790 · Laerdal California, Inc. · Anesthesiology device
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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

FDA 510(k) Submission Details - K843790

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
25d slower than avg
Panel avg: 140d · This submission: 165d
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 21
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K843790.
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
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · Respironics, Inc. · Oct 1982
N-D0-SURE
K811185 · Ackrad Laboratories · Jun 1981
ENDOTRACHEAL TUBE HOLDER
K802601 · Hudson Oxygen Therapy Sales Co. · Dec 1980