Cleared Special

The NOxBOXi Nitric Oxide Delivery System (K201339) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201339 · Praxair, Inc. · Anesthesiology device
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Jun 2020
Decision
30d
Days
Class 2
Risk

K201339 is an FDA 510(k) clearance for the The NOxBOXi Nitric Oxide Delivery System. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Praxair, Inc. (Danbury, US). The FDA issued a Cleared decision on June 19, 2020 after a review of 30 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.

View all Praxair, Inc. devices

Submission Details

510(k) Number K201339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2020
Decision Date June 19, 2020
Days to Decision 30 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
109d faster than avg
Panel avg: 139d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Emergo Global Consulting, LLC
Sarah Marie Fitzgerald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 12
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K201339.
Ulspira TS Nitric Oxide Therapy System
K212409 · Airgas Therapeutics · Jun 2023
Inomax DSIR
K211153 · Mallinckrodt Manufacturing, LLC · Apr 2023
NOxBOXi Nitric Oxide Delivery System
K220898 · Linde Gas & Equipment, Inc. · Apr 2022
INOmax DSIR Plus
K200389 · Mallinckrodt Manufacturing, LLC · Jun 2020
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
K193481 · International Biomedical · Mar 2020
NOxBOXi Nitric Oxide Delivery System
K171696 · Praxair Distribution, Inc. · Oct 2018