510(k) · Cleared
ClearedKEGEL8 Pelvic Exerciser, Model Oph 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ne Services, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Sep 12, 2008 as substantially equivalent to K033256 (Athena Feminine Technologies, Inc., 2003) after a 108-day review. Its family tree reaches back 4 generations to 1989. 12 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891773 (1989). 9 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 3 generations backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- 2 generations backK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- 1 generation backK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- This deviceK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- Descendant · cites it directly · 10 of its ownK141643 YarlapInternational Trade Group, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK191312 Perfect PFETenscare, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK160773 Yarlap IIInternational Trade Group, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK260178 Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252601 Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L)…Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K141643YarlapInternational Trade Group, Inc. · 2015 · cites it directly10descendants
- K191312Perfect PFETenscare, Ltd. · 2019 · 2 generations on3descendants
- K160773Yarlap IIInternational Trade Group, Inc. · 2016 · 2 generations on2descendants
- K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −3 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| −2 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| −1 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| 0 (this device) | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| +1 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
| +2 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| +2 | K160773 | Yarlap II | International Trade Group, Inc. | 2016 | — |
| +3 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026 | — |
| +3 | K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle… | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K033256 | Athena Pelvic Muscle Trainer IISummary page 1…ncontinence in women 4. Substantial Equivalence The 'Kegel8' Pelvic Muscle Trainer is substantially equivalent to: Athena Pelvic Muscle Trainer II (K03325 6). SECTION 5.0 5. Performance Studies… | 2003 |
What descends from it? (12)
See all 123 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K141643 (International Trade Group, Inc., 2015) has gone furthest, with 10 descendants of its own.
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. 2008, 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?
The 'Kegel8' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081480: KEGEL8 Pelvic Exerciser, Model Oph 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081480
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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