# K254304: iNOS intraoral biosensor

- Pathway: 510(k) (Traditional)
- Applicant: Achaemenid, LLC
- Decided: Aug 25, 2026 after 237 days
- Product code: PLC (Sleep Appliances With Patient Monitoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K882303 (1989). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230532: RADx Intraoral Appliance for Snoring and Sleep Apnea, Achaemenid, LLC (2023) Summary page 5.
- K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA), Prosomnus Sleep Technologies (2026). Cleared while this submission was under review Summary page 5.

## Indications for use
The iNOS intraoral biosensor is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Additionally, the fully embedded oximeter sensor measures, displays, stores and transmits functional oxygen saturation of the arterial hemoglobin (SpO2). It is intended for continuous data collection during sleep. It can be used in sleep labs, long term care, hospitals and home use. The device is intended to be applied in the oral cavity. The device is intended for use under non-motion conditions in well perfused areas. The device is single patient, reusable.

Source page: https://510kreport.com/device/K254304
Methodology: https://510kreport.com/methodology