Cleared Traditional

K023014 - VIANOX DELIVERY SYSTEM, MODEL I

K023014 is an FDA 510(k) clearance for VIANOX DELIVERY SYSTEM, manufactured by Pulmonox Medical, Inc.. The device is a Class 2 Anesthesiology device with product code MRP cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K023014 · Pulmonox Medical, Inc. · Anesthesiology device
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Aug 2003
Decision
338d
Days
Class 2
Risk

K023014 is an FDA 510(k) clearance for the VIANOX DELIVERY SYSTEM, MODEL I. Classified as Analyzer, Nitric Oxide (product code MRP), Class II - Special Controls.

Submitted by Pulmonox Medical, Inc. (Edmonton, Ab, CA). The FDA issued a Cleared decision on August 14, 2003 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2380 - 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. Elevated predicate reliance profile. 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 Pulmonox Medical, Inc. devices

FDA 510(k) Submission Details - K023014

510(k) Number K023014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2002
Decision Date August 14, 2003
Days to Decision 338 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
198d slower than avg
Panel avg: 140d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRP Device Classification - Class 2, Special Controls

Product Code MRP Analyzer, Nitric Oxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2380
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.