510(k) · Cleared
ClearedBTL-398
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Feb 10, 2025 as substantially equivalent to K181497 (BTL Industries, Inc., 2018) after a 257-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Feb 10, 2025
- Review
- 257 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K930530 (1995). 36 ancestors in all, the oldest K813008 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 6 generations between
- 3 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 2 generations backK134020 IntonemvIncontrol Medical, LLC · 2014
- 1 generation backK181497 HPM-6000UFBTL Industries, Inc. · 2018
- This deviceK241516 BTL-398BTL Industries, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 9 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 8 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 7 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 6 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 5 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 4 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 3 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 2 generations backK134020 IntonemvIncontrol Medical, LLC · 2014
- 1 generation backK181497 HPM-6000UFBTL Industries, Inc. · 2018
- This deviceK241516 BTL-398BTL Industries, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −9 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −8 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −7 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −6 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −5 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −4 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| −3 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| −2 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| −1 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| 0 (this device) | K241516 | BTL-398 | BTL Industries, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K181497 | HPM-6000UFSummary page 6…K241516 Page 2 of 5 3. Predicate Device Identification K181497 HPM-6000UF BTL Industries, Inc. The predicate device was never subjected to a design related recall. 4. Device Description The… | 2018 |
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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 36 ancestors has a recall.
- 5 other devices also cite its predicate K181497.
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. 2025, 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 entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241516: BTL-398.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241516
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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