Cleared Traditional

K914965 - DISPOSABLE STYLETTE WITH END CAP (FDA 510(k) Clearance)

Class I Anesthesiology device.

K914965 · Pivic Promedco · Anesthesiology device
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May 1992
Decision
204d
Days
Class 1
Risk

K914965 is an FDA 510(k) clearance for the DISPOSABLE STYLETTE WITH END CAP. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Pivic Promedco (Orange, US). The FDA issued a Cleared decision on May 27, 1992 after a review of 204 days - an extended review 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: 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.

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Submission Details

510(k) Number K914965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date May 27, 1992
Days to Decision 204 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 139d · This submission: 204d
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.