510(k) · Cleared
ClearedPelvic Muscle Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colonial Medical Supply · HIR Perineometer
Cleared on Dec 27, 2000 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Dec 27, 2000
- Review
- 107 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- Descendant · cites it directly · 4 of its ownK021115 GyneflexNaissance Holdings, LC · 2002
- Descendant · cites it directly · 2 of its ownK141893 Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014
- Descendant · 2 generations on · 2 of its ownK121902 NatratoneOrelle Corporation, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK171896 Feminine Personal Trainer (FPT)Ralston Group · 2017
- Descendant · 2 generations on · 1 of its ownK162689 Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K021115GyneflexNaissance Holdings, LC · 2002 · cites it directly4descendants
- K141893Vibrance Kegel Device (VKD)Bioinfinity (M) Sdn. Bhd. · 2014 · cites it directly2descendants
- K121902NatratoneOrelle Corporation, Ltd. · 2013 · 2 generations on2descendants
- K171896Feminine Personal Trainer (FPT)Ralston Group · 2017 · 3 generations on1descendant
- K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002830 | Pelvic Muscle Therapy | Colonial Medical Supply | 2000 | — |
| +1 | K021115 | Gyneflex | Naissance Holdings, LC | 2002 | — |
| +1 | K141893 | Vibrance Kegel Device (VKD) | Bioinfinity (M) Sdn. Bhd. | 2014 | — |
| +2 | K121902 | Natratone | Orelle Corporation, Ltd. | 2013 | — |
| +3 | K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017 | — |
| +2 | K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K021115 (Naissance Holdings, LC, 2002) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K002830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002830: Pelvic Muscle Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002830
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026