Cleared Traditional

K961837 - RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

K961837 is an FDA 510(k) clearance for RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MA..., manufactured by Rusch Intl.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K961837 · Rusch Intl. · Anesthesiology device
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Aug 1996
Decision
95d
Days
Class 2
Risk

K961837 is an FDA 510(k) clearance for the RUSH ORAL/NASAL TRACHEAL TUBE CUFFED 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 August 16, 1996 after a review of 95 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K961837

510(k) Number K961837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date August 16, 1996
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 176
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K961837.
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
K962389 · Unomedical Sdn Bhd · Nov 1996
ESOPHAGEAL INTUBATION DETECTOR
K962098 · Kirk Specialty Systems · Oct 1996
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
K955495 · Rusch, Inc. · Jun 1996
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
K961840 · Rusch Intl. · Jun 1996
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
K960795 · Vygon Corp. · May 1996