510(k) · Cleared
ClearedMicrogyn Plus Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Dec 19, 2001 as substantially equivalent to K963222 (Hollister, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Dec 19, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891773 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −1 | K963222 | Microgyn Plus Stimulation Device | Hollister, Inc. | 1996 | — |
| 0 (this device) | K013141 | Microgyn Plus Stimulation Device | Hollister, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K963222 | Microgyn Plus Stimulation DeviceSummary page 1…860 Date Summary Prepared — December 18, 2001 2. Name of Device: Hollister Microgyn Plus Stimulation Device 3. Name of Predicate Device(s) InCare Microgyn Plus Device, K963222 Elpha 2000 Conti Device, K964738 4. Description of Device The proposed Microgyn Plus Stimulation Device is intended to provide e… | 1996 |
| * | K964738 | Elpha 2000 ContiSummary page 1…ber 18, 2001 2. Name of Device: Hollister Microgyn Plus Stimulation Device 3. Name of Predicate Device(s) InCare Microgyn Plus Device, K963222 Elpha 2000 Conti Device, K964738 4. Description of Device The proposed Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the pur… | 1997 |
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 12 years and passes through 1 company; a new generation was cleared every 7.2 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K963222.
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.
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?
The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.
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/K013141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013141: Microgyn Plus Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013141
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026