510(k) · Cleared
ClearedVibrance Pelvic Trainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioinfinity (M) Sdn. Bhd. · HIR Perineometer
Cleared on Jun 8, 2017 as substantially equivalent to K141893 (Bioinfinity (M) Sdn. Bhd., 2014) after a 254-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 8, 2017
- Review
- 254 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002830 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- 1 generation backK141893 Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014
- This deviceK162689 Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017
- Descendant · cites it directly · 0 of its ownK200409 Pelvital SystemPelvital USA, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200409Pelvital SystemPelvital USA, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002830 | Pelvic Muscle Therapy | Colonial Medical Supply | 2000 | — |
| −1 | K141893 | Vibrance Kegel Device (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014 | — |
| 0 (this device) | K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017 | — |
| +1 | K200409 | Pelvital System | Pelvital USA, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 12.4 · 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 |
|---|---|---|---|
| * | K141893 | Vibrance Kegel Device (VKD)Summary page 5…HIR (Perineometer) Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) K141893, Bioinfinity (M) Sdn. Bhd. Vibrance® Kegel Device (VKD) The predicate device has not been subject to a design-related recall.… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200409 | Pelvital System | 2020 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200409 (Pelvital USA, Inc., 2020) has gone furthest, with 0 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. 2017, 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 Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162689: Vibrance Pelvic Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162689
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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