Cleared Traditional

K862435 - DOUBLE LUMEN E T ADAPTOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K862435 · Acutronic Medical Systems AG · Anesthesiology device
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Oct 1986
Decision
118d
Days
Class 1
Risk

K862435 is an FDA 510(k) clearance for the DOUBLE LUMEN E T ADAPTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Acutronic Medical Systems AG (Jona-Rapper Swril, CH). The FDA issued a Cleared decision on October 22, 1986 after a review of 118 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 Acutronic Medical Systems AG devices

Submission Details

510(k) Number K862435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date October 22, 1986
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 139d · This submission: 118d
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.