Cleared Traditional

K961840 - RUSCH ORAL/NASAL TRACHEAL TUBE

K961840 is the FDA 510(k) clearance for RUSCH ORAL/NASAL TRACHEAL TUBE by Rusch Intl.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K961840 · Rusch Intl. · Anesthesiology device
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Jun 1996
Decision
45d
Days
Class 2
Risk

K961840 is an FDA 510(k) clearance for the RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY. 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 June 27, 1996 after a review of 45 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 Rusch Intl. devices

Submission Details

510(k) Number K961840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date June 27, 1996
Days to Decision 45 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
95d faster than avg
Panel avg: 140d · This submission: 45d
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 K961840.
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
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · Vygon Corp. · May 1996
RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
K954585 · Rusch Intl. · May 1996
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994