Cleared Traditional

K955495 - RUSCH REINFORCED TRACHAEL TUBE CUFFED

K955495 is an FDA 510(k) clearance for RUSCH REINFORCED TRACHAEL TUBE CUFFED, manufactured by Rusch, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K955495 · Rusch, Inc. · Anesthesiology device
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Jun 1996
Decision
209d
Days
Class 2
Risk

K955495 is an FDA 510(k) clearance for the RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 209 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, Inc. devices

FDA 510(k) Submission Details - K955495

510(k) Number K955495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date June 27, 1996
Days to Decision 209 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
69d slower than avg
Panel avg: 140d · This submission: 209d
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 133
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K955495.
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
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
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K954585 · Rusch Intl. · May 1996