Cleared Traditional

K897046 - LASER RESISTANT TRACHEAL TUBE

K897046 is an FDA 510(k) clearance for LASER RESISTANT TRACHEAL TUBE, manufactured by Sheridan Catheter Corp.. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K897046 · Sheridan Catheter Corp. · Anesthesiology device
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Mar 1990
Decision
95d
Days
Class 2
Risk

K897046 is an FDA 510(k) clearance for the LASER RESISTANT TRACHEAL TUBE. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - 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 Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K897046

510(k) Number K897046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 23, 1990
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBI Device Classification - Class 2, Special Controls

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 21
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K897046.
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1996
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · Smiths Industries Medical Systems, Inc. · Oct 1995
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
K925615 · Sorin Biomedica, Fiat, USA, Inc. · Mar 1993
TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
K851856 · Sheridan Catheter Corp. · May 1985