510(k) · Cleared
ClearedIncare Pelvic Floor Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · HIR Perineometer
Cleared on Mar 19, 2002 as substantially equivalent to K930530 (Hollister, Inc., 1995) and 3 other predicates after a 134-day review. Its family tree reaches back 3 generations to 1995. 38 later devices descend from it.
- Decided
- Mar 19, 2002
- Review
- 134 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K930530 (1995). 4 ancestors in all. 38 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 2 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 1 generation backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- This deviceK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- Descendant · cites it directly · 37 of its ownK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- Descendant · 2 generations on · 36 of its ownK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · 3 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 2 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K050483Evadri Bladder Control SystemsHollister, Inc. · 2005 · cites it directly37descendants
- K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006 · 2 generations on36descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 3 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 2 generations on21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −2 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −1 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| 0 (this device) | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| +1 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| +2 | 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 | — |
| +2 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 HIR? 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 HIR device
- #1 K252748 Pelvic Floor Exerciser (PF01)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncSummary page 1…0 Date Summary Prepared — November 2, 2001 2. Name of Device: InCare Pelvic Floor Therapy System. 3. Name of Predicate Device(s) 1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048 2. Elpha 2000 Conti Device, K964738 4. Description of Device The InCare Pelvic Floor Therapy System is a… | 1995 |
| * | K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…ary Prepared — November 2, 2001 2. Name of Device: InCare Pelvic Floor Therapy System. 3. Name of Predicate Device(s) 1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048 2. Elpha 2000 Conti Device, K964738 4. Description of Device The InCare Pelvic Floor Therapy System is an office ba… | 1996 |
| * | K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…— November 2, 2001 2. Name of Device: InCare Pelvic Floor Therapy System. 3. Name of Predicate Device(s) 1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048 2. Elpha 2000 Conti Device, K964738 4. Description of Device The InCare Pelvic Floor Therapy System is an office based instrumen… | 1997 |
| * | K964738 | Elpha 2000 ContiSummary page 1…e: InCare Pelvic Floor Therapy System. 3. Name of Predicate Device(s) 1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048 2. Elpha 2000 Conti Device, K964738 4. Description of Device The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by phy… | 1997 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050483 | Evadri Bladder Control Systems | 2005 | 37 |
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 7 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050483 (Hollister, Inc., 2005) has gone furthest, with 37 descendants of its own.
- 6 other devices also cite its predicate K930530.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIR
187in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIR
No recall names HIR since 2007.
Adverse event reports per year · HIR
1in 2024
MAUDE reports naming product code HIR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 3 | 29 | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 187 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for 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/K013612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013612: Incare Pelvic Floor Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013612
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026