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510(k) K254304

iNOS intraoral biosensor by Achaemenid, LLC — Product Code PLC

K254304 is an FDA 510(k) premarket notification submitted by Achaemenid, LLC for the device "iNOS intraoral biosensor". The FDA issued a decision of Substantially Equivalent on August 25, 2026. The device falls under product code PLC (Sleep Appliances With Patient Monitoring), a Class II device regulated under 21 CFR 872.5570. Achaemenid, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2026
Date Received
December 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleep Appliances With Patient Monitoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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 clearances by Achaemenid, LLC

  • K230532 — RADx Intraoral Appliance for Snoring and Sleep Apnea (July 12, 2023)

Other clearances for product code PLC

  • K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (April 6, 2026)
  • K233497 — Rest Assure System (October 3, 2024)
  • K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (April 10, 2020)
  • K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (April 19, 2019)
  • K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device (November 22, 2017)
  • K170606 — Acrylic Herbst Appliance with Micro-Recorder (November 16, 2017)
  • K161624 — MicrO2 OSA Device with Micro-Recorder (November 7, 2016)
  • K160239 — TAP 3, TAP 1 (August 10, 2016)
  • K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)

FDA data resources