Cleared Traditional

K013321 - SILICONE TRACHEAL T-TUBES

K013321 is an FDA 510(k) clearance for SILICONE TRACHEAL T-TUBES, manufactured by Technical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K013321 · Technical Products, Inc. · Anesthesiology device
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Jun 2002
Decision
242d
Days
Class 2
Risk

K013321 is an FDA 510(k) clearance for the SILICONE TRACHEAL T-TUBES. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Technical Products, Inc. (Decatur, US). The FDA issued a Cleared decision on June 4, 2002 after a review of 242 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 Technical Products, Inc. devices

FDA 510(k) Submission Details - K013321

510(k) Number K013321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2001
Decision Date June 04, 2002
Days to Decision 242 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 140d · This submission: 242d
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 159
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K013321.
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
RUSCH MICROLARYNGEAL TUBE
K023964 · Rusch Intl. · Dec 2002
RUSCH EDGAR TUBE
K021540 · Rusch Intl. · Aug 2002
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K993786 · Rusch Intl. · Feb 2000
MODIFICATION TO LASER-SHIELD II
K993582 · Xomed, Inc. · Jan 2000
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
K990619 · Rusch Intl. · Aug 1999