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 Oct 23, 1996 as substantially equivalent to K891773 (Hollister, Inc., 1989) and 2 other predicates after a 68-day review. Its family tree reaches back 1 generation to 1989. 26 later devices descend from it.
- Decided
- Oct 23, 1996
- Review
- 68 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K891773 (1989). 3 ancestors in all. 26 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- This deviceK963222 Microgyn Plus Stimulation DeviceHollister, Inc. · 1996
- Descendant · cites it directly · 14 of its ownK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- Descendant · 3 generations on · 12 of its ownK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- Descendant · 4 generations on · 10 of its ownK141643 YarlapInternational Trade Group, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK973096 Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc. · 1998
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003 · cites it directly14descendants
- K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003 · 2 generations on13descendants
- K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008 · 3 generations on12descendants
- K141643YarlapInternational Trade Group, Inc. · 2015 · 4 generations on10descendants
- K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc. · 1998 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| 0 (this device) | K963222 | Microgyn Plus Stimulation Device | Hollister, Inc. | 1996 | — |
| +1 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| +2 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| +3 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| +4 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
| +1 | K973096 | Neotonus Model 1000 Muscle Stimulator System | Neotonus, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiSummary page 1…mmary Prepared - August 14, 1996 2. Name of Device: Hollister Microgyn Plus Stimulation Device 3. Name of Predicate Device(s) . InCare Microgyn II Stimulation Device, K891773 . InCare PRS9300 Pelvic Floor Therapy System, K930530C . Empi Innova Stimulation device, K910081/A 4. Description of Device The… | 1989 |
| * | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncSummary page 1…ollister Microgyn Plus Stimulation Device 3. Name of Predicate Device(s) . InCare Microgyn II Stimulation Device, K891773 . InCare PRS9300 Pelvic Floor Therapy System, K930530C . Empi Innova Stimulation device, K910081/A 4. Description of Device The Microgyn Plus Stimulation Device is intended to provi… | 1995 |
| * | K910081 | TBDSummary page 1…3. Name of Predicate Device(s) . InCare Microgyn II Stimulation Device, K891773 . InCare PRS9300 Pelvic Floor Therapy System, K930530C . Empi Innova Stimulation device, K910081/A 4. Description of Device The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose… | 1991 |
What descends from it? (26)
See all 263 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?
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/K963222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963222: Microgyn Plus Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963222
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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