510(k) · Cleared
ClearedPeriCoach OTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analytica, Ltd. · HIR Perineometer
Cleared on Jul 11, 2016 as substantially equivalent to K143580 (Analytica, Ltd., 2015) after a 115-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Jul 11, 2016
- Review
- 115 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002617 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002617 Periform Perineometric Probe, Model 8300Neen Design, Ltd. · 2001
- 1 generation backK143580 PeriCoachAnalytica, Ltd. · 2015
- This deviceK160758 PeriCoach OTCAnalytica, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK221476 PerifitX6 Innovations · 2023
- Descendant · 2 generations on · 1 of its ownK231780 Perifit Care+X6 Innovations · 2023
- Descendant · 3 generations on · 0 of its ownK252748 Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | 2001 | — |
| −1 | K143580 | PeriCoach | Analytica, Ltd. | 2015 | — |
| 0 (this device) | K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 | — |
| +1 | K221476 | Perifit | X6 Innovations | 2023 | — |
| +2 | K231780 | Perifit Care+ | X6 Innovations | 2023 | — |
| +3 | K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K143580 | PeriCoachSummary page 4…PeriCoach® OTC Common Name: Perineometer Classification Name: (21CFR 884.1425) Perineometer Product Code: HIR Predicate: PeriCoach® (K143580) Intended Use: The PeriCoach® OTC is a perineometer designed to treat stress, mild- moderate urge… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221476 | Perifit | 2023 | 2 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221476 (X6 Innovations, 2023) has gone furthest, with 2 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. 2016, 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 PeriCoach® OTC is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160758: PeriCoach OTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160758
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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