510(k) · Cleared
ClearedInnovo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantic Therapeutics, Ltd. · QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Cleared on Jan 16, 2020 as substantially equivalent to DEN170049 (Bio-Medical Research, Ltd., 2018) after a 140-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jan 16, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- QAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170049 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170049 InnovoBio-Medical Research, Ltd. · 2018
- This deviceK192357 InnovoAtlantic Therapeutics, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018 | — |
| 0 (this device) | K192357 | Innovo | Atlantic Therapeutics, Ltd. | 2020 | — |
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.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN170049.
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. 2020, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192357: Innovo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192357
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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