FDA-Cleared Sleep Appliances With Patient Monitoring (Product Code PLC): All 10 510(k)s

FDA groups devices by product code. Code PLC is "Sleep Appliances With Patient Monitoring" (FDA classification record). The most recent clearance is K254304 ("iNOS intraoral biosensor", August 25, 2026); the oldest is K150369 (June 18, 2015).

Brand pages for this product code

All 10 records, newest first

FDA 510(k) records under product code PLC
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K254304	iNOS intraoral biosensor	Achaemenid, LLCBoston, MA	August 25, 2026	PLC	Substantially Equivalent
K252765	ProSomnus RPMO2 OSA Device (RPMO2 OSA)	Prosomnus Sleep TechnologiesPleasanton, CA	April 6, 2026	PLC	Substantially Equivalent
K233497	Rest Assure System	Somnomed, Inc.Plano, TX	October 3, 2024	PLC	Substantially Equivalent
K190353	Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac	Residential Home Sleep ServicesBattle Creek, MI	April 10, 2020	PLC	Substantially Equivalent
K181571	OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor	Mark Abramson, D.D.S., Inc.Redwood City, CA	April 19, 2019	PLC	Substantially Equivalent
K172859	Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder	Prosomnous Sleep TechnologiesPleasanton, CA	November 22, 2017	PLC	Substantially Equivalent
K170606	Acrylic Herbst Appliance with Micro-Recorder	Gergen'S Orthodontic LabPhoenix, AZ	November 16, 2017	PLC	Substantially Equivalent
K161624	MicrO2 OSA Device with Micro-Recorder	Microdental, Inc.Dublin, CA	November 7, 2016	PLC	Substantially Equivalent
K160239	TAP 3, TAP 1	Airway Management, Inc.Carrollton, TX	August 10, 2016	PLC	Substantially Equivalent
K150369	SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder	Somnomed, Inc.Frisco, TX	June 18, 2015	PLC	Substantially Equivalent

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.

Search every record by name, company or K-number in the FDA clearance lookup.