510(k) · Cleared
ClearedInner Peace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamabry, Inc., Dba Inner Peace For Women · HIR Perineometer
Cleared on Oct 4, 2013 as substantially equivalent to K021115 (Naissance Holdings, LC, 2002) and 2 other predicates after a 387-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 4, 2013
- Review
- 387 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002830 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View 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) | K122800 | Inner Peace | Kamabry, Inc., Dba Inner Peace For Women | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (3)
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…Product 51 0(k) # Naissance Holdings L.C. GyneFlex 021115 Colonial Medical Supply Pelvic Muscle Therapy 002830 KegelMaster 2000 Ltd… | 2002 |
| * | K002830 | Pelvic Muscle TherapySummary page 1…ance Holdings L.C. GyneFlex 021115 Colonial Medical Supply Pelvic Muscle Therapy 002830 KegelMaster 2000 Ltd Kegelmaster K023305 DEVICE DESCRIPTION… | 2000 |
| * | K023305 | Kegelmaster 2000Summary page 1…ial Medical Supply Pelvic Muscle Therapy 002830 KegelMaster 2000 Ltd Kegelmaster K023305 DEVICE DESCRIPTION 807.92(a)(4) Inner Peace"' is a one-piece, silicone intravaginal… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 10.8 years on median.
- None of the 3 ancestors has a recall.
- 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?
The Inner Peace pelvic exercise device is recommended for the strengthening of perincal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122800: Inner Peace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122800
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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