Cleared Traditional

K952100 - RUSCH ENDOTRACHEAL TUBE STYLET (FDA 510(k) Clearance)

Class I Anesthesiology device.

K952100 · Rusch, Inc. · Anesthesiology device
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Aug 1995
Decision
96d
Days
Class 1
Risk

K952100 is an FDA 510(k) clearance for the RUSCH ENDOTRACHEAL TUBE STYLET. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 96 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K952100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1995
Decision Date August 08, 1995
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 139d · This submission: 96d
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.