510(k) · Cleared
ClearedGyneflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naissance Holdings, LC · HIR Perineometer
Cleared on Dec 20, 2002 as substantially equivalent to K002830 (Colonial Medical Supply, 2000) after a 256-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Dec 20, 2002
- Review
- 256 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002830 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- This deviceK021115 GyneflexNaissance Holdings, LC · 2002
- Descendant · cites it directly · 2 of its ownK121902 NatratoneOrelle Corporation, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK171896 Feminine Personal Trainer (FPT)Ralston Group · 2017
- Descendant · 3 generations on · 0 of its ownK193364 Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose · 2020
- Descendant · cites it directly · 0 of its ownK122800 Inner PeaceKamabry, Inc., Dba Inner Peace For Women · 2013
Most influential descendants
Showing 4 of 4 · See all- K121902NatratoneOrelle Corporation, Ltd. · 2013 · cites it directly2descendants
- K171896Feminine Personal Trainer (FPT)Ralston Group · 2017 · 2 generations on1descendant
- K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose · 2020 · 3 generations on0descendants
- K122800Inner PeaceKamabry, Inc., Dba Inner Peace For Women · 2013 · cites it directly0descendants
View 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) | K021115 | Gyneflex | Naissance Holdings, LC | 2002 | — |
| +1 | K121902 | Natratone | Orelle Corporation, Ltd. | 2013 | — |
| +2 | K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017 | — |
| +3 | K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 2020 | — |
| +1 | K122800 | Inner Peace | Kamabry, Inc., Dba Inner Peace For Women | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 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 1…LEGALLY MARKETED DEVICE The Colonial Medical Supply Pelvic Muscle Therapy was cleared for marketing on December 27, 2000, in premarket notification K002830. Naissance Holdings, L.C., submits this premarket notification f o r GyneFlex. B. DEVICE DESCRIPTION… | 2000 |
What descends from it? (4)
2 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?
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 | — |
What is it indicated for?
The GyneFlex is recommended for the strengthening of the perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021115 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021115: Gyneflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021115
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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