# K240328: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

- Pathway: 510(k) (Special)
- Applicant: Signifier Medical Technologies, Ltd.
- Decided: May 16, 2024 after 101 days
- Product code: QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 872.5575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K223446 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223446: eXciteOSA without remote control (3000);  eXciteOSA with remote control (6000), Signifier Medical Technologies, Ltd. (2023) Summary page 5.

## Indications for use
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.

Source page: https://510kreport.com/device/K240328
Methodology: https://510kreport.com/methodology