510(k) · Cleared
ClearedKegelmaster 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kegelmaster 2000, Ltd. · HIR Perineometer
Cleared on Dec 26, 2002 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 26, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023305 Kegelmaster 2000Kegelmaster 2000, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK122800 Inner PeaceKamabry, Inc., Dba Inner Peace For Women · 2013
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K023305 | Kegelmaster 2000 | Kegelmaster 2000, Ltd. | 2002 | — |
| +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 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K122800 | Inner Peace | 2013 | 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?
- Of its descendants, K122800 (Kamabry, Inc., Dba Inner Peace For Women, 2013) 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.
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 Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023305: Kegelmaster 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023305
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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