510(k) · Cleared
ClearedPelvic Floor Exerciser (PF01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Accurate Bio-Medical Technology Co., Ltd. · HIR Perineometer
Cleared on Apr 27, 2026 as substantially equivalent to K231780 (X6 Innovations, 2023) after a 241-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Apr 27, 2026
- Review
- 241 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002617 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK002617 Periform Perineometric Probe, Model 8300Neen Design, Ltd. · 2001
- 4 generations backK143580 PeriCoachAnalytica, Ltd. · 2015
- 3 generations backK160758 PeriCoach OTCAnalytica, Ltd. · 2016
- 2 generations backK221476 PerifitX6 Innovations · 2023
- 1 generation backK231780 Perifit Care+X6 Innovations · 2023
- This deviceK252748 Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | 2001 | — |
| −4 | K143580 | PeriCoach | Analytica, Ltd. | 2015 | — |
| −3 | K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 | — |
| −2 | K221476 | Perifit | X6 Innovations | 2023 | — |
| −1 | K231780 | Perifit Care+ | X6 Innovations | 2023 | — |
| 0 (this device) | K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026 | — |
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 K231780 Perifit Care+score 10.4 · 4 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 |
|---|---|---|---|
| * | K231780 | Perifit Care+Summary page 5…Product Code HIR 3. PREDICATE DEVICE Predicate Devices: Perifit Care+ 510(k) number K231780 Company Name X6 Innovations The predicate device has not been subject to a design related re… | 2023 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Pelvic Floor Exerciser 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.
Pelvic Floor Exerciser is indicated for an adult female.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252748: Pelvic Floor Exerciser (PF01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252748
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026