Is the TAP appliance FDA approved? FDA 510(k) Clearances Checked

Short answer: TAP (Airway Management) has 7 FDA 510(k) clearances on record, not an FDA approval. The most recent is K252374 ("Nylon flexTAP(R)"), decided September 11, 2025 for Airway Technologies D/B/A Airway Management (Farmers Branch, TX). The earliest in this list is K962516, decided September 10, 1996.

Product codes: LRK (Device, Anti-Snoring, Class II, 21 CFR 872.5570), PLC (Sleep Appliances With Patient Monitoring, Class II, 21 CFR 872.5570)
Applicants as filed: Airway Technologies D/B/A Airway Management; Airway Management, Inc.; Nellcor Puritan Bennett, Inc.
FDA decision on every record listed: Substantially Equivalent (cleared)

TAP (Airway Management) 510(k) records

FDA 510(k) records for TAP (Airway Management)
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K252374	Nylon flexTAP(R)	Airway Technologies D/B/A Airway ManagementFarmers Branch, TX	September 11, 2025	LRK	Substantially Equivalent
K181482	myTAP2	Airway Management, Inc.Carrollton, TX	August 31, 2018	LRK	Substantially Equivalent
K160239	TAP 3, TAP 1	Airway Management, Inc.Carrollton, TX	August 10, 2016	PLC	Substantially Equivalent
K062951	TAP III ANTI-SNORING DEVICE	Airway Management, Inc.Dallas, TX	December 12, 2006	LRK	Substantially Equivalent
K061732	TAP-T	Airway Management, Inc.Dallas, TX	July 12, 2006	LRK	Substantially Equivalent
K060388	TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT	Airway Management, Inc.Dallas, TX	May 17, 2006	LRK	Substantially Equivalent
K962516	TAP ANTI-SNORING DEVICE	Nellcor Puritan Bennett, Inc.Eden Prairie, MN	September 10, 1996	LRK	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 TAP (Airway Management) 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 TAP (Airway Management) "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 TAP (Airway Management) 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).