De Novo · Granted
GrantedInnovo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Granted on Nov 6, 2018 as a new device type through De Novo after a 414-day review. 4 later devices descend from it.
- Decided
- Nov 6, 2018
- Review
- 414 days
- Class
- Class II
- Product code
- QAJ
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN170049 InnovoBio-Medical Research, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK183585 Elitone DeviceElidah, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK253285 Elitone for MenElidah, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK223884 ELITONE Urge Urinary Incontinence DeviceElidah, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK192357 InnovoAtlantic Therapeutics, Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K183585Elitone DeviceElidah, Inc. · 2019 · cites it directly2descendants
- K253285Elitone for MenElidah, Inc. · 2026 · 2 generations on0descendants
- K223884ELITONE Urge Urinary Incontinence DeviceElidah, Inc. · 2023 · 2 generations on0descendants
- K192357InnovoAtlantic Therapeutics, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018 | — |
| +1 | K183585 | Elitone Device | Elidah, Inc. | 2019 | — |
| +2 | K253285 | Elitone for Men | Elidah, Inc. | 2026 | — |
| +2 | K223884 | ELITONE Urge Urinary Incontinence Device | Elidah, Inc. | 2023 | — |
| +1 | K192357 | Innovo | Atlantic Therapeutics, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K183585 (Elidah, Inc., 2019) has gone furthest, with 2 descendants of its own.
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. 2018, 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?
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
The Innovo is indicated for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170049 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170049: Innovo.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170049
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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