Cleared Traditional

K802505 - DOUBLE LUMEN TRACHEAL TUBE

K802505 is the FDA 510(k) clearance for DOUBLE LUMEN TRACHEAL TUBE by National Catheter Co. Div. Mallinckrodt. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K802505 · National Catheter Co. Div. Mallinckrodt · Anesthesiology device
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Mar 1981
Decision
149d
Days
Class 2
Risk

K802505 is an FDA 510(k) clearance for the DOUBLE LUMEN TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by National Catheter Co. Div. Mallinckrodt (Walker, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 National Catheter Co. Div. Mallinckrodt devices

Submission Details

510(k) Number K802505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date March 13, 1981
Days to Decision 149 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 140d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 67
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K802505.
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · Mallinckrodt Critical Care · Jul 1981
CONCEPT ENDOTRACHEAL TUBE
K801213 · Concept, Inc. · May 1980
MODEL GV-10 LANZ PRESSURE-VALVE
K791045 · Extracorporeal Medical Specialities, Inc. · Jun 1979
ENDOTRACHEAL TUBES, LONG & SHORT TERM
K791046 · Extracorporeal Medical Specialities, Inc. · Jun 1979