510(k) · Cleared
ClearedPelvital System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelvital USA, Inc. · HIR Perineometer
Cleared on Jul 10, 2020 as substantially equivalent to K162689 (Bioinfinity (M) Sdn. Bhd., 2017) after a 142-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jul 10, 2020
- Review
- 142 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002830 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- 2 generations backK141893 Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014
- 1 generation backK162689 Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017
- This deviceK200409 Pelvital SystemPelvital USA, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K162689 | Vibrance Pelvic TrainerSummary page 5…oduct Code: HIR Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) K162689, Bioinfinity (M) Sdn. Bhd., Vibrance Pelvic Trainer 6. Device Description The Pelvital System is a repeat use, a non-sterile… | 2017 |
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 20 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 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. 2020, 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 Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women
with stress 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/K200409 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200409: Pelvital System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200409
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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