Cleared Traditional

K912652 - FLEX-ELBOW (FDA 510(k) Clearance)

Class I Anesthesiology device.

K912652 · Vital Signs, Inc. · Anesthesiology device
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Oct 1991
Decision
115d
Days
Class 1
Risk

K912652 is an FDA 510(k) clearance for the FLEX-ELBOW. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on October 10, 1991 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K912652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date October 10, 1991
Days to Decision 115 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
24d faster than avg
Panel avg: 139d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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.