510(k) · Cleared
ClearedYarlap II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Trade Group, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on May 4, 2016 as substantially equivalent to K141643 (International Trade Group, Inc., 2015) after a 44-day review. Its family tree reaches back 6 generations to 1989. 2 later devices descend from it.
- Decided
- May 4, 2016
- Review
- 44 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. 2 later devices descend from it, 2 citing it directly.
- 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 deviceK160773 Yarlap IIInternational Trade Group, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK252601 Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L)…Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241862 Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K160773 | Yarlap II | International Trade Group, Inc. | 2016 | — |
| +1 | K252601 | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle… | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026 | — |
| +1 | K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics, Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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…d electrode used with the device to stimulate the muscle of the female pelvic floor (the electrode, essential technology and intended use are identical to the Predicate: K141643). The Applicant device is supplied with a biofeedback reference lead wire with a skin electrode(s). The Applicant device control… | 2015 |
What descends from it? (2)
2 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 27 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K252601 (Hunan Accurate Bio-Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2016, 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 device 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 as stated in the FDA summary.
https://510kreport.com/device/K160773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160773: Yarlap II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160773
Report an extraction error
Are you the manufacturer?
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