Nox Medical

Reykjavik, IS

NOX MEDICAL appears in FDA device records in Reykjavik, IS. FDA records list 3 510(k) clearances between 2008-11-07 and 2019-11-13, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 2

510(k) clearance history

FDA records hold 3 510(k) clearances for Nox Medical between 2008 and 2019. The busiest year on record is 2008, with 1. The most recent is 2019, with 1.

Clearances by year, as a table

510(k) clearance decisions for Nox Medical, by decision year
Year	Clearances
2008	1
2013	1
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K192469	Nox Sleep System	OLZ	Substantially Equivalent	2019-11-13
K124062	QDC-PRO, AND NOX-RIP	MNR	Substantially Equivalent	2013-07-10
K082113	NOX T3, NOXTURNAL (PC APPLICATION)	MNR	Substantially Equivalent	2008-11-07

Registered establishments

FDA registered establishments for Nox Medical, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007389703	3007389703	NOX MEDICAL	Katrinartuni 2, Reykjavik IS-105 IS	2026	CAT DQA IKD KZM MNR OLV OLZ QVO
3015665860	3015665860	NOX MEDICAL LLC	100 Kimball Place, Alpharetta, GA 30009 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0031-2022	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.	Class II	2021-09-07	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain