Cleared Traditional

K934465 - DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE

K934465 is an FDA 510(k) clearance for DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K934465 · Smiths Industries Medical Systems, Inc. · Anesthesiology device
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Jan 1994
Decision
123d
Days
Class 2
Risk

K934465 is an FDA 510(k) clearance for the DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 123 days - within the typical 510(k) review window.

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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K934465

510(k) Number K934465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1993
Decision Date January 14, 1994
Days to Decision 123 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
17d faster than avg
Panel avg: 140d · This submission: 123d
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 149
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K934465.
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · B&B Medical Technologies, Inc. · Nov 1994
ENDOPLUS
K941969 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
RAE II TRACHEAL TUBE
K941246 · Mallinckrodt Medical · Apr 1994
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K925507 · Rusch, Inc. · Sep 1993