# K233251: NOxBOXi Nitric Oxide Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Linde Gas & Equipment, Inc.
- Decided: May 23, 2024 after 238 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003665 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
5 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231823: NOxBOXi Nitric Oxide Delivery System, Linde Gas & Equipment, Inc. (2023) Summary page 5.

## Recalls of this device
- Sep 14, 2026 · Class II · Z-3306-2026: Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
- Aug 19, 2026 · Class II · Z-3165-2026: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- Sep 9, 2025 · Class I · Z-0028-2026: 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 fl
- Sep 9, 2025 · Class I · Z-0029-2026: 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.

## Indications for use
NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO). The NOxBOXi Nitric Oxide Delivery System includes: • The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode. • Continuous monitoring and alarms for NO, O2, and NO2. • The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO, mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals. The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (currently neonates). Refer to this material prior to use.

Source page: https://510kreport.com/device/K233251
Methodology: https://510kreport.com/methodology