The NOxBOXi Nitric Oxide Delivery System

510(k) K201339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK201339	Date19 Jun 2020Cleared	StatusActive

4 recalls · 4 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)