Data / Medical devices / Iceland / Nox Medical

Nox Medical: FDA-registered device maker in Reykjavik, Iceland, 10 510(k) clearances

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

Nox Medical is registered with the FDA (registration 3007389703) in Reykjavik, Iceland. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 20, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007389703
Address: Katrinartuni 2, Reykjavik, Iceland, IS-105
Owner or operator: Nox Medical (10027652)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 21, 2008
Registered through: 2026
Brand names listed: DeepRESP, Nox A1 Carry Case, Nox A1 EEG 5 Lead Gold Electrode Cable, Nox A1 EEG Head Cable, Nox A1 Recorder, Nox A1 Starter Sensor Kit, Adult, Nox A1 Starter Sensor Kit, Pediatric, Nox A1 System and more

Devices it lists

Device	Product code	Class	Role	Source
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Specification developer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Specification developer	accessdata.fda.gov
Computerized Behavioral Therapy Device For Insomnia	QVO	2	Manufacturer	accessdata.fda.gov
Device, Muscle Monitoring	KZM	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer, Specification developer	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
March 20, 2026	K260585	Noxturnal Web	OLV	Substantially Equivalent	Nox Medical Ehf	accessdata.fda.gov
November 17, 2025	K252330	DeepRESP	OLZ	Substantially Equivalent	Nox Medical Ehf	accessdata.fda.gov
March 14, 2025	K241960	DeepRESP	OLZ	Substantially Equivalent	Nox Medical Ehf	accessdata.fda.gov
December 23, 2024	K241288	Noxturnal Web	OLV	Substantially Equivalent	Nox Medical Ehf	accessdata.fda.gov
March 23, 2020	K191716	Somryst	QVO	Substantially Equivalent	Pear Therapeutics, Inc.	accessdata.fda.gov
November 13, 2019	K192469	Nox Sleep System	OLZ	Substantially Equivalent	Nox Medical	accessdata.fda.gov
November 6, 2015	K151361	Nox RIP Belts & Cables	MNR	Substantially Equivalent	Nox Medical Ehf	accessdata.fda.gov
December 22, 2010	K102350	PULSE OXIMETER	DQA	Substantially Equivalent	Nonin Medical, Inc.	accessdata.fda.gov
October 21, 2009	K092101	REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES	DQA	Substantially Equivalent	Nonin Medical, Inc.	accessdata.fda.gov
November 7, 2008	K082113	NOX T3, NOXTURNAL (PC APPLICATION)	MNR	Substantially Equivalent	Nox Medical	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 7, 2021	88673	Class II	Terminated	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.	Error in the device firmware results in the inaccurate detection of device position.	accessdata.fda.gov

Compare with other makers

Updated March 20, 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.