510(k) · Cleared
ClearedPeriform Perineometric Probe, Model 8300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neen Design, Ltd. · HIR Perineometer
Cleared on Apr 5, 2001 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 5, 2001
- Review
- 225 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK002617 Periform Perineometric Probe, Model 8300Neen Design, Ltd. · 2001
- Descendant · cites it directly · 4 of its ownK143580 PeriCoachAnalytica, Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK160758 PeriCoach OTCAnalytica, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK221476 PerifitX6 Innovations · 2023
- Descendant · 4 generations on · 1 of its ownK231780 Perifit Care+X6 Innovations · 2023
- Descendant · 5 generations on · 0 of its ownK252748 Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K143580PeriCoachAnalytica, Ltd. · 2015 · cites it directly4descendants
- K160758PeriCoach OTCAnalytica, Ltd. · 2016 · 2 generations on3descendants
- K221476PerifitX6 Innovations · 2023 · 3 generations on2descendants
- K231780Perifit Care+X6 Innovations · 2023 · 4 generations on1descendant
- K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | 2001 | — |
| +1 | K143580 | PeriCoach | Analytica, Ltd. | 2015 | — |
| +2 | K160758 | PeriCoach OTC | Analytica, Ltd. | 2016 | — |
| +3 | K221476 | Perifit | X6 Innovations | 2023 | — |
| +4 | K231780 | Perifit Care+ | X6 Innovations | 2023 | — |
| +5 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143580 | PeriCoach | 2015 | 4 |
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?
- Of its descendants, K143580 (Analytica, Ltd., 2015) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K002617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002617: Periform Perineometric Probe, Model 8300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002617
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026