Cleared Special

K240328 - eXciteOSA without remote control (3000) (FDA 510(k) Clearance)

Also includes:
eXciteOSA with remote control (6000)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240328 · Signifier Medical Technologies, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
101d
Days
Class 2
Risk

K240328 is an FDA 510(k) clearance for the eXciteOSA without remote control (3000). Classified as Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea (product code QNO), Class II - Special Controls.

Submitted by Signifier Medical Technologies, Ltd. (London, GB). The FDA issued a Cleared decision on May 16, 2024 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5575 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Signifier Medical Technologies, Ltd. devices

Submission Details

510(k) Number K240328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2024
Decision Date May 16, 2024
Days to Decision 101 days
Submission Type Special
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
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5575
Definition A Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Consists Of A Removable Intraoral Mouthpiece That Uses Electrodes To Deliver Neuromuscular Stimulation To The Tongue To Strengthen Tongue Musculature To Reduce Snoring And Obstructive Sleep Apnea.
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

Regchoice, LLC
Darren Scheer

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.