Cleared Traditional

K965132 - HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

K965132 is an FDA 510(k) clearance for HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES, manufactured by Mallinckrodt Medical. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K965132 · Mallinckrodt Medical · Anesthesiology device
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Mar 1997
Decision
87d
Days
Class 2
Risk

K965132 is an FDA 510(k) clearance for the HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on March 20, 1997 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

FDA 510(k) Submission Details - K965132

510(k) Number K965132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 20, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
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 186
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K965132.
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
K971759 · Green Field Medical Sourcing, Inc. · Mar 1998
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
K973191 · Pulmonx · Feb 1998
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K962389 · Unomedical Sdn Bhd · Nov 1996
ESOPHAGEAL INTUBATION DETECTOR
K962098 · Kirk Specialty Systems · Oct 1996
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K961837 · Rusch Intl. · Aug 1996