510(k) · Cleared
ClearedContimed II Biofeedback Dev Treat of Urin Inconti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · HIR Perineometer
Cleared on Aug 23, 1989 after a 152-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 23, 1989
- Review
- 152 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK891774 Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc. · 1989
- Descendant · cites it directly · 5 of its ownK013653 Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure…Hollister, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK133990 Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014
- Descendant · 3 generations on · 3 of its ownK180637 leva Pelvic Floor TrainerRenovia, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK192270 LEva Pelvic Digital Health SystemRenovia, Inc. · 2019
- Descendant · 5 generations on · 1 of its ownK212495 Leva Pelvic Health SystemRenovia, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K013653Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure ProbeHollister, Inc. · 2002 · cites it directly5descendants
- K133990Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014 · 2 generations on4descendants
- K180637leva Pelvic Floor TrainerRenovia, Inc. · 2018 · 3 generations on3descendants
- K192270LEva Pelvic Digital Health SystemRenovia, Inc. · 2019 · 4 generations on2descendants
- K212495Leva Pelvic Health SystemRenovia, Inc. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| +1 | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe | Hollister, Inc. | 2002 | — |
| +2 | K133990 | Ieva Rehabilitative Positional Device | Remendium Labs, LLC | 2014 | — |
| +3 | K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018 | — |
| +4 | K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019 | — |
| +5 | K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
3 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?
- Of its descendants, K013653 (Hollister, Inc., 2002) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K891774 · printed Nov 3, 2026
Cite this page
510(k) Report. “K891774: Contimed II Biofeedback Dev Treat of Urin Inconti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K891774
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026