510(k) · Cleared
ClearedElitone for Men
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 Jan 23, 2026 as substantially equivalent to K183585 (Elidah, Inc., 2019) after a 116-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Jan 23, 2026
- Review
- 116 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 K223884 ELITONE Urge Urinary Incontinence Devicescore 5.2 · 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 5…876.5330 Product Code(s) QAJ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K183585 Elitone QAJ Device Description Summary 21 CFR 807.92(a)(4) The Elitone for Men device is an electrical muscle stimulator designe… | 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 8 years and passes through 2 companies; a new generation was cleared every 6.9 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. 2026, 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 for Men is a non-implanted muscle stimulator designed to aid early continence recovery in men immediately following prostate surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253285: Elitone for Men.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253285
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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