510(k) · Cleared
ClearedPeriCoach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analytica, Ltd. · HIR Perineometer
Cleared on Mar 18, 2015 as substantially equivalent to K002617 (Neen Design, Ltd., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Mar 18, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002617 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002617 Periform Perineometric Probe, Model 8300Neen Design, Ltd. · 2001
- This deviceK143580 PeriCoachAnalytica, Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK160758 PeriCoach OTCAnalytica, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK221476 PerifitX6 Innovations · 2023
- Descendant · 3 generations on · 1 of its ownK231780 Perifit Care+X6 Innovations · 2023
- Descendant · 4 generations on · 0 of its ownK252748 Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K160758PeriCoach OTCAnalytica, Ltd. · 2016 · cites it directly3descendants
- K221476PerifitX6 Innovations · 2023 · 2 generations on2descendants
- K231780Perifit Care+X6 Innovations · 2023 · 3 generations on1descendant
- K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | 2001 | — |
| 0 (this device) | K143580 | PeriCoach | Analytica, Ltd. | 2015 | — |
| +1 | K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 | — |
| +2 | K221476 | Perifit | X6 Innovations | 2023 | — |
| +3 | K231780 | Perifit Care+ | X6 Innovations | 2023 | — |
| +4 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K002617 | Periform Perineometric Probe, Model 8300Summary page 4…oach® Common Name: Perineometer Classification Name: (21CFR 884.1425) Perineometer Product Code: HIR Predicate: Neen Healthcare Periform (K002617) Intended Use: The PeriCoach® is a perineometer designed to treat stress, mild- moderate urge and… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160758 | PeriCoach OTC | 2016 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K160758 (Analytica, Ltd., 2016) has gone furthest, with 3 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. 2015, 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 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/K143580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143580: PeriCoach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143580
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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