Cleared Traditional

K904974 - TRACH COLLAR

K904974 is an FDA 510(k) clearance for TRACH COLLAR, manufactured by Rotek Corp.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K904974 · Rotek Corp. · Anesthesiology device
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Jan 1991
Decision
80d
Days
Class 1
Risk

K904974 is an FDA 510(k) clearance for the TRACH COLLAR. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Rotek Corp. (Albuquerque, US). The FDA issued a Cleared decision on January 11, 1991 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K904974

510(k) Number K904974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date January 11, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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 34
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K904974.
ENDO TRACHEA TUBE FIXATION
K924551 · M. Imonti and Associates Inc., · Dec 1992
AGA TRACH TIES
K922657 · Aga Medical Products, Inc. · Jul 1992
E.T. TAPE II
K912884 · B&B Medical Technologies, Inc. · Jul 1991
SALTER LABS MODEL #1015
K903539 · Salter Labs · Dec 1990
BABY E.T. TAPE II
K900912 · B&B Medical Technologies, Inc. · Aug 1990
E.T. TAPE II
K902065 · B&B Medical Technologies, Inc. · Jul 1990
K904974 · TRACH COLLAR
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