Cleared Traditional

K904999 - WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K904999 · Opticon Medical, Inc. · Anesthesiology device
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Jan 1993
Decision
812d
Days
Class 1
Risk

K904999 is an FDA 510(k) clearance for the WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Opticon Medical, Inc. (Gurnee, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 812 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Opticon Medical, Inc. devices

Submission Details

510(k) Number K904999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1990
Decision Date January 26, 1993
Days to Decision 812 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
673d slower than avg
Panel avg: 139d · This submission: 812d
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.