Cleared Traditional

K043205 - RUSCH EASY TUBE

K043205 is an FDA 510(k) clearance for RUSCH EASY TUBE, manufactured by Teleflex Medical. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K043205 · Teleflex Medical · Anesthesiology device
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Jan 2005
Decision
49d
Days
Class 2
Risk

K043205 is an FDA 510(k) clearance for the RUSCH EASY TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 49 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 Teleflex Medical devices

FDA 510(k) Submission Details - K043205

510(k) Number K043205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date January 07, 2005
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
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 K043205.
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007
AMSINO ENDOTRACHEAL TUBE
K050785 · Amsino International, Inc. · Jul 2005
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