510(k) · Cleared
ClearedHPM-6000UF
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 Nov 14, 2018 as substantially equivalent to K162010 (BTL Industries, Inc., 2016) and 1 other predicate after a 160-day review. Its family tree reaches back 9 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 14, 2018
- Review
- 160 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930530 (1995). 35 ancestors in all, the oldest K813008 (1981). 6 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 5 generations between
- 3 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 2 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 1 generation backK134020 IntonemvIncontrol Medical, LLC · 2014
- This deviceK181497 HPM-6000UFBTL Industries, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK262353 BTL-299-FBTL Industries, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252334 PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER…Pontemedag · 2026
- Descendant · cites it directly · 0 of its ownK251026 Regenesis EMS ChairTrinity Medical Solutions · 2025
- Descendant · cites it directly · 0 of its ownK241516 BTL-398BTL Industries, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230780 MFG-05Zimmer Medizinsysteme GmbH · 2023
Show all 9 generations
- Root · 9 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 8 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 7 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 6 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 5 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 4 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 3 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 2 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 1 generation backK134020 IntonemvIncontrol Medical, LLC · 2014
- This deviceK181497 HPM-6000UFBTL Industries, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K262353BTL-299-FBTL Industries, Inc. · 2026 · cites it directly0descendants
- K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag · 2026 · cites it directly0descendants
- K251026Regenesis EMS ChairTrinity Medical Solutions · 2025 · cites it directly0descendants
- K241516BTL-398BTL Industries, Inc. · 2025 · cites it directly0descendants
- K230780MFG-05Zimmer Medizinsysteme GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −8 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −7 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −6 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −5 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −4 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −3 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| −2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| −1 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| 0 (this device) | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| +1 | K262353 | BTL-299-F | BTL Industries, Inc. | 2026 | — |
| +1 | K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS)… | Pontemedag | 2026 | — |
| +1 | K251026 | Regenesis EMS Chair | Trinity Medical Solutions | 2025 | — |
| +1 | K241516 | BTL-398 | BTL Industries, Inc. | 2025 | — |
| +1 | K230780 | MFG-05 | Zimmer Medizinsysteme GmbH | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K162010 | HPM-6000USummary page 4…the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: Primary predicate - HPM-6000U (K162010) Secondary predicate - InToneMV (K134020) Page 1 of 5… | 2016 |
| * | K134020 | IntonemvSummary page 4…for distribution in the USA under the following 510(k) Premarket Notification numbers: Primary predicate - HPM-6000U (K162010) Secondary predicate - InToneMV (K134020) Page 1 of 5… | 2014 |
What descends from it? (6)
6 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 23 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 35 ancestors has a recall.
- Of its descendants, K262353 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2018, 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?
HPM-6000UF 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181497: HPM-6000UF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181497
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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