Data / Medical devices / United Kingdom / Noxbox Limited

Noxbox Limited: FDA-registered device maker in Sittingbourne Kent, United Kingdom, 1 510(k) clearance

Name: Noxbox Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Noxbox Limited is registered with the FDA (registration 3012796317) in Sittingbourne Kent, United Kingdom. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2024. 6 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012796317
Address: 1 Eurolink Gateway Castle Road, Sittingbourne Kent, United Kingdom, ME10 3AG
Owner or operator: NOxBOX Limited (10058545)
Roles: Manufacturer
First device listed: January 15, 2026
Registered through: 2026
Brand names listed: NOxBOXi Nitric Oxide Delivery and Monitoring System

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer	accessdata.fda.gov
Analyzer, Nitric Oxide	MRP	2	Manufacturer	accessdata.fda.gov
Analyzer, Nitrogen Dioxide	MRQ	2	Manufacturer	accessdata.fda.gov
Apparatus, Nitric Oxide Delivery	MRN	2	Manufacturer	accessdata.fda.gov
Apparatus, Nitric Oxide, Backup Delivery	MRO	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 23, 2024	K233251	NOxBOXi Nitric Oxide Delivery System	MRN	Substantially Equivalent	Linde Gas & Equipment, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 14, 2026	99816	Class II	Ongoing	NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.	Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.	accessdata.fda.gov
August 19, 2026	99621	Class II	Ongoing	NOxBOXi Nitric Oxide Delivery System.	Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.	accessdata.fda.gov
September 9, 2025	97517	Class I	Ongoing	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I	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	accessdata.fda.gov
September 9, 2025	97516	Class I	Ongoing	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I	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.	accessdata.fda.gov
July 19, 2023	97417	Class II	Ongoing	NOxBOXi Nitric Oxide Delivery System	Replacement of the internal Sample Pump due to high failure rates.	accessdata.fda.gov
May 3, 2023	92171	Class I	Terminated	NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device	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 asso	accessdata.fda.gov

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Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.