Is the ResMed Narval FDA approved? FDA 510(k) Clearances Checked

Short answer: ResMed Narval CC has a FDA 510(k) clearance on record, not an FDA approval. The most recent is K113201 ("NARVAL CC"), decided December 1, 2011 for Resmed Sas (San Diego, CA).

Product code: LQZ (Device, Jaw Repositioning, Class II, 21 CFR 872.5570)
Applicant as filed: Resmed Sas
FDA decision on every record listed: Substantially Equivalent (cleared)

ResMed Narval CC 510(k) records

FDA 510(k) records for ResMed Narval CC
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K113201	NARVAL CC	Resmed SasSan Diego, CA	December 1, 2011	LQZ	Substantially Equivalent

Each 510(k) number links to FDA's own record, where you can read the summary or statement and the intended use. We grouped these records under ResMed Narval CC by device and applicant name; if a product you are looking at is sold under a different name, search the lookup or FDA's database directly.

Is ResMed Narval CC "FDA approved"?

Not in FDA's sense of the word. Anti-snoring and jaw-repositioning mouthpieces are Class II devices that reach the market through a 510(k) premarket notification. FDA "clears" a 510(k) when it finds the device substantially equivalent to one already legally sold. "Approval" is a different process (premarket approval, or PMA) used mainly for higher-risk Class III devices. So the accurate phrase for ResMed Narval CC is "FDA cleared", for the specific models and dates in the table above.

What this page is, and what it is not

This is a copy of public FDA records, not a review. 40 Winks has not tested these devices for this page.
A 510(k) clearance means FDA found a device substantially equivalent to a device already legally on the market. It is not an FDA approval, it is not an endorsement by FDA or by 40 Winks, and it does not show that a device will work for you. FDA's own rule (21 CFR 807.97) says a 510(k) clearance does not mean FDA has approved the device.
A clearance covers the specific device and model in the filing. Check that the product you are buying matches the 510(k) number and name, and read the intended use in FDA's record.
Loud, regular snoring can be a sign of obstructive sleep apnea. Talk to a doctor or a dentist trained in sleep medicine before relying on a mouthpiece, and ask whether a sleep test makes sense.

How to check a clearance yourself

Open FDA's 510(k) Premarket Notification database.
Search by the 510(k) number (it starts with K) or by the device or company name.
Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

Other sleep devices in this lookup

Search all 254 sleep-appliance records in the FDA clearance lookup, or browse by product code: Anti-Snoring Devices (LRK), Jaw Repositioning Devices (LQZ), Sleep Appliances With Patient Monitoring (PLC).