Cleared Traditional

K931164 - RUSCH AGT PVC PREFORM NASAL TRACH TUB/C...

K931164 is an FDA 510(k) clearance for RUSCH AGT PVC PREFORM NASAL TRACH TUB/C..., 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 107-day FDA review.

K931164 · Rusch, Inc. · Anesthesiology device
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Jun 1993
Decision
107d
Days
Class 2
Risk

K931164 is an FDA 510(k) clearance for the RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY. 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 23, 1993 after a review of 107 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, Inc. devices

FDA 510(k) Submission Details - K931164

510(k) Number K931164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 23, 1993
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 K931164.
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · Rusch, Inc. · Aug 1993
RAE(R) II TRACHEAL TUBE
K932280 · Mallinckrodt Medical · Jul 1993
RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE
K931163 · Rusch, Inc. · Jun 1993
RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE
K931165 · Rusch, Inc. · Jun 1993
RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
K931166 · Rusch, Inc. · Jun 1993
LAZER-TRACH TRACHEAL TUBE
K922894 · Sheridan Catheter Corp. · May 1993