Cleared Special

K033779 - VIANOX DELIVERY SYSTEM, MODEL II

K033779 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 MRN cleared through the Special 510(k) pathway after a 53-day FDA review.

K033779 · Pulmonox Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
53d
Days
Class 2
Risk

K033779 is an FDA 510(k) clearance for the VIANOX DELIVERY SYSTEM, MODEL II. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Pulmonox Medical, Inc. (Edmonton, Ab, CA). The FDA issued a Cleared decision on January 26, 2004 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033779

510(k) Number K033779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date January 26, 2004
Days to Decision 53 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 140d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

MRN Device Classification - Class 2, Special Controls

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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 - MRN Apparatus, Nitric Oxide Delivery

All 33
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K033779.
INOMAX DS
K071516 · Ino Therapeutics, LLC · Oct 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867 · Ino Therapeutics, LLC · Apr 2007
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K061901 · Ino Therapeutics · Dec 2006
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
K000653 · Pulmonox Medical Corp. · Aug 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · Datex-Ohmeda · Feb 2000
OHMEDA INOVENT DELIVERY SYSTEM
DEN000001 · Ohmeda Medical · Jan 2000
K033779 · VIANOX DELIVERY SYSTEM, MODEL II
Download PDF FDA Summary Pulmonox Medical, Inc.