Cleared Traditional

K940799 - FLEXGUIDE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K940799 · Scientific Sales Intl., Inc. · Anesthesiology device
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Aug 1994
Decision
177d
Days
Class 1
Risk

K940799 is an FDA 510(k) clearance for the FLEXGUIDE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 177 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.

View all Scientific Sales Intl., Inc. devices

Submission Details

510(k) Number K940799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date August 18, 1994
Days to Decision 177 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
38d slower than avg
Panel avg: 139d · This submission: 177d
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.