510(k) · Cleared
ClearedHPM-6000U
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 Dec 13, 2016 as substantially equivalent to K973096 (Neotonus, Inc., 1998) after a 146-day review. Its family tree reaches back 4 generations to 1989. 7 later devices descend from it.
- Decided
- Dec 13, 2016
- Review
- 146 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891773 (1989). 10 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 3 generations backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- 2 generations backK970307 Minnova Pelvic Floor Stimulation SystemEmpi · 1997
- 1 generation backK973096 Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc. · 1998
- This deviceK162010 HPM-6000UBTL Industries, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK262353 BTL-299-FBTL Industries, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252334 PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER…Pontemedag · 2026
- Descendant · 2 generations on · 0 of its ownK251026 Regenesis EMS ChairTrinity Medical Solutions · 2025
- Descendant · 2 generations on · 0 of its ownK241516 BTL-398BTL Industries, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181497HPM-6000UFBTL Industries, Inc. · 2018 · cites it directly6descendants
- K262353BTL-299-FBTL Industries, Inc. · 2026 · 2 generations on0descendants
- K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag · 2026 · 2 generations on0descendants
- K251026Regenesis EMS ChairTrinity Medical Solutions · 2025 · 2 generations on0descendants
- K241516BTL-398BTL Industries, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −3 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| −2 | K970307 | Minnova Pelvic Floor Stimulation System | Empi | 1997 | — |
| −1 | K973096 | Neotonus Model 1000 Muscle Stimulator System | Neotonus, Inc. | 1998 | — |
| 0 (this device) | K162010 | HPM-6000U | BTL Industries, Inc. | 2016 | — |
| +1 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| +2 | K262353 | BTL-299-F | BTL Industries, Inc. | 2026 | — |
| +2 | K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS)… | Pontemedag | 2026 | — |
| +2 | K251026 | Regenesis EMS Chair | Trinity Medical Solutions | 2025 | — |
| +2 | K241516 | BTL-398 | BTL Industries, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973096 | Neotonus Model 1000 Muscle Stimulator SystemSummary page 4…that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number: Neotonus Model 1000 Muscle Stimulator System (K973096) 0 – Page 1 of 5… | 1998 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181497 | HPM-6000UF | 2018 | 6 |
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 6.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K181497 (BTL Industries, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K973096.
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?
HPM-6000U 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 urinary incontinence in women.
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/K162010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162010: HPM-6000U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162010
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