510(k) · Cleared
ClearedLevina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zmi Electronics, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jan 18, 2024 as substantially equivalent to K222528 (Well-Life Healthcare Limited, 2022) after a 268-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Jan 18, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K891773 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 4 generations backK970602 Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc. · 1997
- 3 generations backK971541 Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc. · 1997
- 2 generations backK122194 Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd · 2013
- 1 generation backK222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)…Well-Life Healthcare Limited · 2022
- This deviceK231166 Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic…Zmi Electronics, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −4 | K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-Small | Hollister, Inc. | 1997 | — |
| −3 | K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - Tampon | Hollister, Inc. | 1997 | — |
| −2 | K122194 | Life-Care Vaginal Probe Life-Care Anal Probe | Everyway Medical Instruments Co.,Ltd | 2013 | — |
| −1 | K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life… | Well-Life Healthcare Limited | 2022 | — |
| 0 (this device) | K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor… | Zmi Electronics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
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 KPI? 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 KPI device
- #1 K262353 BTL-299-Fscore 14.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…Summary page 5…oduct Code: KPI Subsequent Product Code: HIR (Obstetrical and Gynecological Diagnostic Devices) 3. Predicate Device Information Primary Predicate 510K Number: K222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) This predicate has not been subject to a design-related rec… | 2022 |
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 35 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All KPI devicesKPI Stimulator, Electrical, Non-Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KPI
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KPI
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPI
No recall names KPI since 2007.
Adverse event reports per year · KPI
2in 2024
MAUDE reports naming product code KPI, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 57 | 0 | 0 |
| 2015 | 6 | 260 | 0 | 2 |
| 2016 | 3 | 89 | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 304 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 3 | 217 | 0 | 1 |
| 2022 | 3 | 181 | 0 | 2 |
| 2023 | 3 | 197 | 0 | 6 |
| 2024 | 4 | 172 | 0 | 2 |
| 2025 | 4 | 263 | 0 | 0 |
| 2026 | 7 | 248 | 0 | — |
What is it indicated for?
Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231166: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231166
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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