510(k) · Cleared
Clearedleva Pelvic Floor Trainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovia, Inc. · HIR Perineometer
Cleared on Apr 4, 2018 as substantially equivalent to K133990 (Remendium Labs, LLC, 2014) after a 23-day review. Its family tree reaches back 3 generations to 1989. 3 later devices descend from it.
- Decided
- Apr 4, 2018
- Review
- 23 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K891774 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK891774 Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc. · 1989
- 2 generations backK013653 Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure…Hollister, Inc. · 2002
- 1 generation backK133990 Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014
- This deviceK180637 leva Pelvic Floor TrainerRenovia, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK192270 LEva Pelvic Digital Health SystemRenovia, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK212495 Leva Pelvic Health SystemRenovia, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK213913 leva Pelvic Health SystemRenovia, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −2 | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe | Hollister, Inc. | 2002 | — |
| −1 | K133990 | Ieva Rehabilitative Positional Device | Remendium Labs, LLC | 2014 | — |
| 0 (this device) | K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018 | — |
| +1 | K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019 | — |
| +2 | K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021 | — |
| +3 | K213913 | leva Pelvic Health System | Renovia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133990 | Ieva Rehabilitative Positional DeviceSummary page 4…HIR (perineometer) Review Panel: Obstetrics/Gynecology Predicate Device Identification 510(k) Number: K133990 Device Name: leva Rehabilitative Positional Device Manufacturer: Remendi… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192270 | LEva Pelvic Digital Health System | 2019 | 2 |
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 29 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K192270 (Renovia, Inc., 2019) has gone furthest, with 2 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. 2018, this device’s year, is highlighted.
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 leva Pelvic Digital Health System is intended for:
1) Strengthening of the pelvic floor muscles;
2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women.
This device interacts with the user via smart phone technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180637 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180637: leva Pelvic Floor Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180637
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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