510(k) · Cleared
ClearedNatratone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orelle Corporation, Ltd. · HIR Perineometer
Cleared on Jun 6, 2013 as substantially equivalent to K021115 (Naissance Holdings, LC, 2002) after a 342-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 6, 2013
- Review
- 342 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002830 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002830 Pelvic Muscle TherapyColonial Medical Supply · 2000
- 1 generation backK021115 GyneflexNaissance Holdings, LC · 2002
- This deviceK121902 NatratoneOrelle Corporation, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK171896 Feminine Personal Trainer (FPT)Ralston Group · 2017
- Descendant · 2 generations on · 0 of its ownK193364 Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose · 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 |
|---|---|---|---|---|---|
| −2 | K002830 | Pelvic Muscle Therapy | Colonial Medical Supply | 2000 | — |
| −1 | K021115 | Gyneflex | Naissance Holdings, LC | 2002 | — |
| 0 (this device) | K121902 | Natratone | Orelle Corporation, Ltd. | 2013 | — |
| +1 | K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017 | — |
| +2 | K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 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 12.5 · 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 |
|---|---|---|---|
| * | K021115 | GyneflexSummary page 1…9 Telephone: (206) 420-4703 Fax: (206) 420-4703 Patricia Coombes Chief Executive Officer May 24, 2013 NatraTone® Perineometer 21 CFR 884.1425 Class Il Device 85 HIR K021115 - The Naissance Holdings, LLC ‘GyneFlex Perineometer JUN 6 21 NatraTone® is a pelvic floor muscle exerciser. It is a single, r… | 2002 |
| † | K032664 | Kotpexin Sphere |
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 |
|---|---|---|---|
| K171896 | Feminine Personal Trainer (FPT) | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171896 (Ralston Group, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K021115.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
NatraTone® is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual’s voluntary contractions of these muscles it seeks to correct, through exercise, Urinary Incontinence in women.
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/K121902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121902: Natratone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121902
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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