Cleared Traditional

K973191 - THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM

K973191 is an FDA 510(k) clearance for THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM..., manufactured by Pulmonx. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K973191 · Pulmonx · Anesthesiology device
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Feb 1998
Decision
172d
Days
Class 2
Risk

K973191 is an FDA 510(k) clearance for the THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Pulmonx (Palo Alto, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 172 days - an extended review 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: 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 Pulmonx devices

FDA 510(k) Submission Details - K973191

510(k) Number K973191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date February 13, 1998
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
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 164
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K973191.
VENTLAB VERIFY II
K990098 · Ventlab Corp. · Feb 1999
AMBU TUBECHECK
K981891 · Ambu, Inc. · Jul 1998
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
K971759 · Green Field Medical Sourcing, Inc. · Mar 1998
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K962389 · Unomedical Sdn Bhd · Nov 1996