510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223446Substantially Equivalent

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Signifier Medical Technologies Limited, London, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223446 is the FDA 510(k) clearance record for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000), a class II device, cleared for Signifier Medical Technologies, Ltd. on under FDA product code QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea). FDA's definition for product code QNO reads: "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...". FDA records list 3 510(k) clearances for Signifier Medical Technologies, Ltd., from to . As of , FDA records show no recalls naming K223446.

Clearance record

Decision date
Received
(64 days to decision)
Product code
QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Regulation
21 CFR 872.5575
Device class
Class II
Review panel
Dental
Applicant
Signifier Medical Technologies, Ltd. 5-17 Hammersmith Grove, London, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNO

Trailing 12 months

FDA records hold no clearances under product code QNO in the trailing twelve months.

FDA records show no clearances under product code QNO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260