Cleared Traditional

K802505 - DOUBLE LUMEN TRACHEAL TUBE

K802505 is an FDA 510(k) clearance for DOUBLE LUMEN TRACHEAL TUBE, manufactured by National Catheter Co. Div. Mallinckrodt. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K802505

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.

BTR Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K802505.
SLICK ENDOTRACHEAL TUBE
K812943 · Polamedco, Inc. · Nov 1981
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · Mallinckrodt Critical Care · Jul 1981
SLICK SET W/SURELOC EXTERNAL CONNECTOR
K810151 · Polamedco, Inc. · Feb 1981
CONCEPT ENDOTRACHEAL TUBE
K801213 · Concept, Inc. · May 1980
OHIO DISPOSABLE TRACHEAL TUBE
K800634 · Ohio Medical Products · Apr 1980