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The Tracker / August 2026 / K254304

510(k) cleared

iNOS intraoral biosensor

Achaemenid, LLC · Aug 25, 2026 · K254304

FDA cleared the iNOS intraoral biosensor from Achaemenid, LLC on Aug 25, 2026 under K254304, a traditional 510(k). The device falls under product code PLC, Sleep Appliances With Patient Monitoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 31, 2025. The decision came 237 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Achaemenid, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254304?

K254304 is the FDA 510(k) for iNOS intraoral biosensor, submitted by Achaemenid, LLC. FDA's decision date was Aug 25, 2026, under product code PLC (Sleep Appliances With Patient Monitoring).

Who makes the iNOS intraoral biosensor?

Achaemenid, LLC, based in Boston, MA, is the applicant of record for K254304.

How long did the K254304 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Aug 25, 2026, 237 days later.

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