510(k) · Cleared
ClearedPerifit Care+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X6 Innovations · HIR Perineometer
Cleared on Dec 20, 2023 as substantially equivalent to K221476 (X6 Innovations, 2023) after a 187-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Dec 20, 2023
- Review
- 187 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002617 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002617 Periform Perineometric Probe, Model 8300Neen Design, Ltd. · 2001
- 3 generations backK143580 PeriCoachAnalytica, Ltd. · 2015
- 2 generations backK160758 PeriCoach OTCAnalytica, Ltd. · 2016
- 1 generation backK221476 PerifitX6 Innovations · 2023
- This deviceK231780 Perifit Care+X6 Innovations · 2023
- Descendant · cites it directly · 0 of its ownK252748 Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | 2001 | — |
| −3 | K143580 | PeriCoach | Analytica, Ltd. | 2015 | — |
| −2 | K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 | — |
| −1 | K221476 | Perifit | X6 Innovations | 2023 | — |
| 0 (this device) | K231780 | Perifit Care+ | X6 Innovations | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K221476 | PerifitSummary page 5…re+ Common or Usual Name: Perineometer Classification Name: (21 CFR 884.1425) Perineometer Regulatory Class: Class II Product Code: HIR Predicate Devices: Perifit (K221476) Intended Use / Indications for Use The Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed… | 2023 |
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 |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01) | 2026 | 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252748 (Hunan Accurate Bio-Medical Technology Co., Ltd., 2026) 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. 2023, 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 Perifit Care+ 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.
Perifit Care+ is indicated for an adult female.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231780: Perifit Care+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231780
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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