510(k) · Cleared
ClearedELITONE Urge Urinary Incontinence Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elidah, Inc. · QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Cleared on Feb 24, 2023 as substantially equivalent to K183585 (Elidah, Inc., 2019) after a 59-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Feb 24, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- QAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170049 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAJ device
- #1 K253285 Elitone for Menscore 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183585 | Elitone DeviceSummary page 4…ification Product Code: QAJ Regulation Number: 876.5330 Device Classification: Class II Predicate Device: ELITONE (K183585), manufactured by Elidah, Inc. The predicate device has not been subject to a design-related recall. Dev… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K183585.
How does its category compare?
All QAJ devicesQAJ Cutaneous Electrode Stimulator For Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QAJ
Too few QAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QAJ
No recall names QAJ since 2007.
Adverse event reports per year · QAJ
1in 2024
MAUDE reports naming product code QAJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223884 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223884: ELITONE Urge Urinary Incontinence Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223884
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026