Cleared Traditional

K955238 - RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE

K955238 is the FDA 510(k) clearance for RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE by Rusch Intl.. It is a Class 1 Anesthesiology device (product code BSR) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K955238 · Rusch Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
84d
Days
Class 1
Risk

K955238 is an FDA 510(k) clearance for the RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 K955238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date February 06, 1996
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 8
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K955238.
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