What is the primary function of the NOxBOXi Nitric Oxide Delivery System?

This apparatus is designed to deliver a constant concentration of nitric oxide to patients undergoing therapy. It simultaneously monitors the levels of nitric oxide, nitrogen dioxide, and oxygen within the inspiratory ventilator lines to ensure accurate administration.

Who is authorized to operate the NOxBOXi system?

The device is intended for use exclusively by healthcare professionals. This ensures that the delivery and monitoring of nitric oxide therapy are managed by trained clinical staff capable of interpreting the system's readings and maintaining patient safety.

Noxboxi Nitric Oxide Delivery System

by Praxair Distribution, Inc.

510(k) K171696

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

510(k) K171696↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK171696	Date2 Oct 2018Cleared	StatusActive

Recalls

6 recalls · 5 ongoing · FDA

- Ongoing Z-3306-2026 FDA Class II initiated 14 Sep 2026
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
- Ongoing Z-3165-2026 FDA Class II initiated 19 Aug 2026
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- Ongoing Z-0028-2026 FDA Class I initiated 9 Sep 2025
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
- Ongoing Z-0029-2026 FDA Class I initiated 9 Sep 2025
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
- Ongoing Z-2544-2025 FDA Class II initiated 19 Jul 2023
Replacement of the internal Sample Pump due to high failure rates.
- Terminated Z-1667-2023 FDA Class I initiated 3 May 2023
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K171696
FDA Product Code: MRN

Device Class: Class II
Regulation: 21 CFR Part 868.5165
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Noxboxi Nitric Oxide Delivery System is an apparatus designed for the delivery and monitoring of a constant concentration of nitric oxide. It is used to monitor nitric oxide, nitrogen dioxide, and oxygen levels within the inspiratory ventilator lines of patients undergoing nitric oxide therapy.

This device is intended for use by healthcare professionals and has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 868.5165.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

What is the primary function of the NOxBOXi Nitric Oxide Delivery System?

This apparatus is designed to deliver a constant concentration of nitric oxide to patients undergoing therapy. It simultaneously monitors the levels of nitric oxide, nitrogen dioxide, and oxygen within the inspiratory ventilator lines to ensure accurate administration.
Who is authorized to operate the NOxBOXi system?

The device is intended for use exclusively by healthcare professionals. This ensures that the delivery and monitoring of nitric oxide therapy are managed by trained clinical staff capable of interpreting the system's readings and maintaining patient safety.
What is the regulatory status of this device?

The NOxBOXi Nitric Oxide Delivery System has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 868.5165, which pertains to apparatuses used for the delivery of nitric oxide.