Cleared Traditional

K053063 - PRO-FLOW MULTIPURPOSE CANNULA

K053063 is an FDA 510(k) clearance for PRO-FLOW MULTIPURPOSE CANNULA, manufactured by Pro-Tech Services, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K053063 · Pro-Tech Services, Inc. · Anesthesiology device
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Dec 2005
Decision
42d
Days
Class 2
Risk

K053063 is an FDA 510(k) clearance for the PRO-FLOW MULTIPURPOSE CANNULA. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Mukilteo, US). The FDA issued a Cleared decision on December 13, 2005 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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: 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 Pro-Tech Services, Inc. devices

FDA 510(k) Submission Details - K053063

510(k) Number K053063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2005
Decision Date December 13, 2005
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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