510(k) · Cleared
ClearedMyOnyx System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thought Technology, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jan 13, 2021 as substantially equivalent to K053434 (Thought Technology, Ltd., 2006) after a 271-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jan 13, 2021
- Review
- 271 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930530 (1995). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 5 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 4 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 3 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 2 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 1 generation backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- This deviceK201014 MyOnyx SystemThought Technology, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK213043 Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −5 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −4 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −3 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −2 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −1 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| 0 (this device) | K201014 | MyOnyx System | Thought Technology, Ltd. | 2021 | — |
| +1 | K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K053434 | Myotrac Infiniti Electrical StimulatorSummary page 4…ectiveness information to provide an understanding of the basis for a determination of substantial equivalence. Predicate Device: MyoTrac Infiniti™ System (K053434, Product codes: KPI, IPF, HCC) Reference Devices • Pathway CTS2000 Pelvic Floor Training System (K023906, Product Code: KPI… | 2006 |
| † | K023906 | Pathway CTS2000 Pelvic Floor Training System | 2003 |
| † | K122194 | Life-Care Vaginal Probe Life-Care Anal Probe | 2013 |
| † | K934552 | Peripump | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213043 | Levator Elite (Model LE9011) | 2022 | 0 |
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 26 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K213043 (Shenzhen Dongdixin Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K053434.
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. 2021, 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 MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.
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/K201014 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201014: MyOnyx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201014
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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