Cleared Traditional

SUCTION T CONNECTOR (K862434) - FDA 510(k) Clearance

K862434 · Acutronic Medical Systems AG · Anesthesiology device
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Jul 1986
Decision
14d
Days
-
Risk

K862434 is an FDA 510(k) clearance for the SUCTION T CONNECTOR.

Submitted by Acutronic Medical Systems AG (Jona-Rapper Swril, CH). The FDA issued a Cleared decision on July 10, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acutronic Medical Systems AG devices

Submission Details

510(k) Number K862434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date July 10, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -