iNOS intraoral biosensor
FDA 510(k) K254304 · Achaemenid, LLC
510(k) numberK254304
Submission
- Device name
- iNOS intraoral biosensor
- Applicant
- Achaemenid, LLC
Boston, MA, US - Received
- December 31, 2025
- Decision date
- August 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLC – Sleep Appliances With Patient Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Specialty
- Dental
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Other 510(k)s with product code PLC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA)PLC · Traditional | Prosomnus Sleep Technologies | 04/06/2026SE |
| K233497 | Rest Assure SystemPLC · Traditional | Somnomed, Inc. | 10/03/2024SE |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracPLC · Traditional | Residential Home Sleep Services | 04/10/2020SE |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorPLC · Traditional | Mark Abramson, D.D.S., Inc. | 04/19/2019SE |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…PLC · Traditional | Prosomnous Sleep Technologies | 11/22/2017SE |
| K170606 | Acrylic Herbst Appliance with Micro-RecorderPLC · Traditional | Gergen'S Orthodontic Lab | 11/16/2017SE |
| K161624 | MicrO2 OSA Device with Micro-RecorderPLC · Traditional | Microdental, Inc. | 11/07/2016SE |
| K160239 | Tap 3, Tap 1PLC · Traditional | Airway Management, Inc. | 08/10/2016SE |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…PLC · Traditional | Somnomed, Inc. | 06/18/2015SE |
More from Somnomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230532 | RADx Intraoral Appliance for Snoring and Sleep ApneaLQZ · Abbreviated | 07/12/2023SE |
Questions and answers
When was iNOS intraoral biosensor cleared by the FDA?
iNOS intraoral biosensor (K254304) received a 510(k) decision of Substantially Equivalent on August 25, 2026, 237 days after the submission was received.
What is the product code of K254304?
The FDA product code is PLC – Sleep Appliances With Patient Monitoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.