510(k) · Cleared
ClearedIncare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · HIR Perineometer
Cleared on Mar 5, 2002 as substantially equivalent to K891774 (Hollister, Inc., 1989) after a 119-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it.
- Decided
- Mar 5, 2002
- Review
- 119 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891774 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK891774 Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc. · 1989
- This deviceK013653 Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure…Hollister, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK133990 Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK180637 leva Pelvic Floor TrainerRenovia, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK192270 LEva Pelvic Digital Health SystemRenovia, Inc. · 2019
- Descendant · 4 generations on · 1 of its ownK212495 Leva Pelvic Health SystemRenovia, Inc. · 2021
- Descendant · 5 generations on · 0 of its ownK213913 leva Pelvic Health SystemRenovia, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K133990Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014 · cites it directly4descendants
- K180637leva Pelvic Floor TrainerRenovia, Inc. · 2018 · 2 generations on3descendants
- K192270LEva Pelvic Digital Health SystemRenovia, Inc. · 2019 · 3 generations on2descendants
- K212495Leva Pelvic Health SystemRenovia, Inc. · 2021 · 4 generations on1descendant
- K213913leva Pelvic Health SystemRenovia, Inc. · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| 0 (this device) | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe | Hollister, Inc. | 2002 | — |
| +1 | K133990 | Ieva Rehabilitative Positional Device | Remendium Labs, LLC | 2014 | — |
| +2 | K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018 | — |
| +3 | K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019 | — |
| +4 | K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021 | — |
| +5 | K213913 | leva Pelvic Health System | Renovia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 12.5 · 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? (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 |
|---|---|---|---|
| * | K891774 | Contimed II Biofeedback Dev Treat of Urin IncontiSummary page 1…dback Vaginal Pressure Probe InCare Pressure Biofeedback Anal Pressure Probe 3. Name of Predicate Device(s) InCare Pressure Biofeedback Vaginal Pressure Probe — 510(k) #K891774 InCare Pressure Biofeedback Anal Pressure Probe — 510(k) #K891774 4. Description of Device The InCare Pressure Biofeedback Vagin… | 1989 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133990 | Ieva Rehabilitative Positional Device | 2014 | 4 |
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?
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 InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in 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/K013653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013653: Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013653
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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