iNOS intraoral biosensor— 510(k) K254304
Substantially EquivalentAchaemenid, LLC
FDA 510(k) clearance K254304 for iNOS intraoral biosensor, Substantially Equivalent on 2026-08-25. Applicant: Achaemenid, LLC. Device class: 2.
Summary
Achaemenid's iNOS intraoral biosensor is filed under product code PLC, sleep appliances with patient monitoring. The record doesn't expand iNOS or describe the sensor further.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Achaemenid filed from Boston, Massachusetts. Review took 237 calendar days (December 31, 2025 to August 25, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Achaemenid, LLC
- Product code
- Product code PLC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code PLC
view all- K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- K233497 — Rest Assure System
- K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
- K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
- K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
More clearances from Achaemenid, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.