Cleared Traditional

K941246 - RAE II TRACHEAL TUBE

K941246 is an FDA 510(k) clearance for RAE II TRACHEAL TUBE, manufactured by Mallinckrodt Medical. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K941246 · Mallinckrodt Medical · Anesthesiology device
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Apr 1994
Decision
27d
Days
Class 2
Risk

K941246 is an FDA 510(k) clearance for the RAE II TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

FDA 510(k) Submission Details - K941246

510(k) Number K941246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1994
Decision Date April 11, 1994
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
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 K941246.
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · B&B Medical Technologies, Inc. · Nov 1994
COLIBRI
K940041 · Icor AB · Jul 1994
ENDOPLUS
K941969 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
K934465 · Smiths Industries Medical Systems, Inc. · Jan 1994
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · Rusch, Inc. · Sep 1993