510(k) · Cleared
ClearedEveryway Incontinence Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instrument Co., Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jul 7, 2017 as substantially equivalent to K141643 (International Trade Group, Inc., 2015) after a 417-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Jul 7, 2017
- Review
- 417 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K891773 (1989). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 5 generations backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- 4 generations backK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- 3 generations backK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- 2 generations backK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- 1 generation backK141643 YarlapInternational Trade Group, Inc. · 2015
- This deviceK161349 Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −5 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| −4 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| −3 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| −2 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| −1 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
| 0 (this device) | K161349 | Everyway Incontinence Stimulation System | Everyway Medical Instrument Co., Ltd. | 2017 | — |
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 |
| 2009 | 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 |
|---|---|---|---|
| * | K141643 | YarlapSummary page 4…il : [email protected] 2. Name of the Device: Everyway Incontinence Stimulation System 3. Information of the 510(k) Cleared Device (Predicate Device): K141643: Yarlap Nonimplanted electrical continence device. K122194: Life-Care Vaginal Probe models PR-02A, PR-03A, PR-04A, PR-14A (for… | 2015 |
| † | K122194 | Life-Care Vaginal Probe Life-Care Anal Probe | 2013 |
| † | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | 2007 |
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 28 years and passes through 6 companies; a new generation was cleared every 6.6 years on median.
- None of the 12 ancestors has a recall.
- 4 other devices also cite its predicate K141643.
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. 2017, 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?
Everyway Incontinence Stimulation System 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
and to maintain urinary continence 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/K161349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161349: Everyway Incontinence Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161349
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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