510(k) · Cleared
ClearedMyotrac Infiniti Electrical Stimulator
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 Mar 15, 2006 as substantially equivalent to K023906 (The Prometheus Group, 2003) and 4 other predicates after a 96-day review. Its family tree reaches back 5 generations to 1995. 36 later devices descend from it.
- Decided
- Mar 15, 2006
- Review
- 96 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K930530 (1995). 10 ancestors in all. 36 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 4 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 3 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 2 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 1 generation backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- This deviceK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · cites it directly · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · cites it directly · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · 3 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · cites it directly34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · cites it directly21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 2 generations on10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 2 generations on9descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −4 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −3 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −2 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −1 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| 0 (this device) | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| +1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +1 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +2 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +2 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +3 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K023906 | Pathway CTS2000 Pelvic Floor Training SystemSummary page 7…the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices; Pathways CTS 2000 pelvic floor training system (K023906), InCare PIRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500… | 2003 |
| * | K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 7…f MyoTrac Infiniti system with the legally marketed predicate devices; Pathways CTS 2000 pelvic floor training system (K023906), InCare PIRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a compa… | 1997 |
| * | K002154 | K.E.A.T.Summary page 7…e devices; Pathways CTS 2000 pelvic floor training system (K023906), InCare PIRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a comparison table is present in the above section. Biocompatibil… | 2001 |
| * | K050483 | Evadri Bladder Control SystemsSummary page 7…y marketed predicate devices; Pathways CTS 2000 pelvic floor training system (K023906), InCare PIRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a comparison table is present in the above secti… | 2005 |
| * | K994109 | Detrusan 500Summary page 7…em (K023906), InCare PIRS Pelvic Floor Therapy System (K974048), Evadri Bladder Control System (K050483), K.E.A.T (K002154) and Detrusan 500 Incontinence Therapy System (K994109). Such a comparison table is present in the above section. Biocompatibility: The Thought Technology Vaginal EMS Sensor (K93214… | 2000 |
| † | K932149 | Thought Technology Vaginal & Rectal Electrode | 1995 |
What descends from it? (36)
See all 364 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 11 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K080950 (Otto Bock, Austria GmbH, 2009) has gone furthest, with 34 descendants of its own.
- 2 other devices also cite its predicate K023906.
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 MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles. The MyoTrac…
Read the full statement (127 words)
The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053434: Myotrac Infiniti Electrical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053434
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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