Cleared Traditional

K970196 - T-WALL UNCUFFED TRACHEAL TUBE

K970196 is an FDA 510(k) clearance for T-WALL UNCUFFED TRACHEAL TUBE, manufactured by Vital Signs, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K970196 · Vital Signs, Inc. · Anesthesiology device
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Aug 1997
Decision
212d
Days
Class 2
Risk

K970196 is an FDA 510(k) clearance for the T-WALL UNCUFFED TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 21, 1997 after a review of 212 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K970196

510(k) Number K970196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date August 21, 1997
Days to Decision 212 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
72d slower than avg
Panel avg: 140d · This submission: 212d
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 K970196.
AMBU TUBECHECK
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THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
K973191 · Pulmonx · Feb 1998
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K962389 · Unomedical Sdn Bhd · Nov 1996
ESOPHAGEAL INTUBATION DETECTOR
K962098 · Kirk Specialty Systems · Oct 1996