Cleared Traditional

K861949 - SUCTION CATHETER KIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K861949 · Medi-Craft , Ltd. · Anesthesiology device
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Oct 1986
Decision
155d
Days
Class 1
Risk

K861949 is an FDA 510(k) clearance for the SUCTION CATHETER KIT. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Medi-Craft , Ltd. (Ontario L4t 1l2, CA). The FDA issued a Cleared decision on October 22, 1986 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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.

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Submission Details

510(k) Number K861949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date October 22, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 139d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.