Cleared Traditional

K925508 - RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP

K925508 is an FDA 510(k) clearance for RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP, 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 297-day FDA review.

K925508 · Rusch, Inc. · Anesthesiology device
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Sep 1993
Decision
297d
Days
Class 2
Risk

K925508 is an FDA 510(k) clearance for the RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP. 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 September 2, 1993 after a review of 297 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 - K925508

510(k) Number K925508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date September 02, 1993
Days to Decision 297 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
157d slower than avg
Panel avg: 140d · This submission: 297d
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 K925508.
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · Rusch, Inc. · Sep 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K925507 · Rusch, Inc. · Sep 1993
BIVONA(R) ICU ENDOTRACHEAL TUBE
K931749 · Bivona Medical Technologies · Aug 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · Rusch, Inc. · Aug 1993
RAE(R) II TRACHEAL TUBE
K932280 · Mallinckrodt Medical · Jul 1993