Cleared Traditional

K954585 - RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ...

K954585 is the FDA 510(k) clearance for RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ... by Rusch Intl.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K954585 · Rusch Intl. · Anesthesiology device
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May 1996
Decision
221d
Days
Class 2
Risk

K954585 is an FDA 510(k) clearance for the RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on May 10, 1996 after a review of 221 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 Rusch Intl. devices

Submission Details

510(k) Number K954585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date May 10, 1996
Days to Decision 221 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
81d slower than avg
Panel avg: 140d · This submission: 221d
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 107
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K954585.
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
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · Vygon Corp. · May 1996
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994
ENDOPLUS
K941969 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
RAE II TRACHEAL TUBE
K941246 · Mallinckrodt Medical · Apr 1994