Cleared Traditional

K254304 - iNOS intraoral biosensor

K254304 is an FDA 510(k) clearance for iNOS intraoral biosensor, manufactured by Achaemenid, LLC. The device is a Class 2 Dental device with product code PLC cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K254304 · Achaemenid, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
237d
Days
Class 2
Risk

K254304 is an FDA 510(k) clearance for the iNOS intraoral biosensor. Classified as Sleep Appliances With Patient Monitoring (product code PLC), Class II - Special Controls.

Submitted by Achaemenid, LLC (Boston, US). The FDA issued a Cleared decision on August 25, 2026 after a review of 237 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Achaemenid, LLC devices

FDA 510(k) Submission Details - K254304

510(k) Number K254304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date August 25, 2026
Days to Decision 237 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 127d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLC Device Classification - Class 2, Special Controls

Product Code PLC Sleep Appliances With Patient Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Aztech Regulatory & Quality, LLC
Joseph Azary

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PLC Sleep Appliances With Patient Monitoring

All 9
Devices cleared under the same product code (PLC) and FDA review panel - the closest regulatory comparables to K254304.
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · Prosomnus Sleep Technologies · Apr 2026
Rest Assure System
K233497 · Somnomed, Inc. · Oct 2024
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
K190353 · Residential Home Sleep Services · Apr 2020
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
K181571 · Mark Abramson, D.D.S., Inc. · Apr 2019
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
K172859 · Prosomnous Sleep Technologies · Nov 2017
Acrylic Herbst Appliance with Micro-Recorder
K170606 · Gergen'S Orthodontic Lab · Nov 2017