510(k) · Cleared
Clearedleva Pelvic Health System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovia, Inc. · HIR Perineometer
Cleared on Jun 30, 2022 as substantially equivalent to K212495 (Renovia, Inc., 2021) after a 197-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Jun 30, 2022
- Review
- 197 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K891774 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK891774 Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc. · 1989
- 5 generations backK013653 Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure…Hollister, Inc. · 2002
- 4 generations backK133990 Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014
- 3 generations backK180637 leva Pelvic Floor TrainerRenovia, Inc. · 2018
- 2 generations backK192270 LEva Pelvic Digital Health SystemRenovia, Inc. · 2019
- 1 generation backK212495 Leva Pelvic Health SystemRenovia, Inc. · 2021
- This deviceK213913 leva Pelvic Health SystemRenovia, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −5 | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe | Hollister, Inc. | 2002 | — |
| −4 | K133990 | Ieva Rehabilitative Positional Device | Remendium Labs, LLC | 2014 | — |
| −3 | K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018 | — |
| −2 | K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019 | — |
| −1 | K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021 | — |
| 0 (this device) | K213913 | leva Pelvic Health System | Renovia, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K212495 | Leva Pelvic Health SystemSummary page 4…84.1425 FDA Panel: Obstetrics / Gynecology 3. Predicate Information 510(k) Number Trade Name Applicant K212495 leva Pelvic Health System Renovia Inc. 4. Device Description The leva Pelvic Health Syst… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 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 (including overactive bladder) in women;
3) Rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) 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/K213913 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213913: leva Pelvic Health System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213913
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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