Cleared Traditional

K970196 - T-WALL UNCUFFED TRACHEAL TUBE

K970196 is the FDA 510(k) clearance for T-WALL UNCUFFED TRACHEAL TUBE by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 117
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K970196.
MODIFICATION TO LASER-SHIELD II
K993582 · Xomed, Inc. · Jan 2000
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K990619 · Rusch Intl. · Aug 1999
AMBU TUBECHECK
K981891 · Ambu, Inc. · Jul 1998
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K961837 · Rusch Intl. · Aug 1996
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
K961840 · Rusch Intl. · Jun 1996