Cleared Traditional

K911425 - ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K911425 · Intersurgical, Inc. · Anesthesiology device
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Jun 1991
Decision
139d
Days
Class 1
Risk

K911425 is an FDA 510(k) clearance for the ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Intersurgical, Inc. (Cazenovia, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 139 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 Intersurgical, Inc. devices

Submission Details

510(k) Number K911425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date June 24, 1991
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 139d · This submission: 139d
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.