# K223446: eXciteOSA without remote control (3000);  eXciteOSA with remote control (6000)

- Pathway: 510(k) (Special)
- Applicant: Signifier Medical Technologies, Ltd.
- Decided: Jan 18, 2023 after 64 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- DEN200018: eXciteOSA with remote and eXciteOSA without remote, Signifier Medical Technologies (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K240328: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (2024), 0 descendants of its own

## 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/K223446
Methodology: https://510kreport.com/methodology