510(k) · Cleared
ClearedVibrance Kegel Device (VKD)
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 Dec 18, 2014 as substantially equivalent to K002830 (Colonial Medical Supply, 2000) after a 157-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 157 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002830 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- This deviceK141893 Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014
- Descendant · cites it directly · 1 of its ownK162689 Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017
- Descendant · 2 generations on · 0 of its ownK200409 Pelvital SystemPelvital USA, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002830 | Pelvic Muscle Therapy | Colonial Medical Supply | 2000 | — |
| 0 (this device) | K141893 | Vibrance Kegel Device (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014 | — |
| +1 | K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017 | — |
| +2 | K200409 | Pelvital System | Pelvital USA, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K002830 | Pelvic Muscle TherapySummary page 5…Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device Colonial Medical Supply Pelvic Muscle Therapy 510(k) Number K002830 6. Device Description The Vibrance Kegel Device (VKD700) is an intra-vaginal exercise device intended to strengthen the p… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162689 | Vibrance Pelvic Trainer | 2017 | 1 |
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?
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Kegel Device (VKD) 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/K141893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141893: Vibrance Kegel Device (VKD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141893
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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