# K002617: Periform Perineometric Probe, Model 8300

- Pathway: 510(k) (Traditional)
- Applicant: Neen Design, Ltd.
- Decided: Apr 5, 2001 after 225 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K143580: PeriCoach (2015), 4 descendants of its own
- K160758: PeriCoach OTC (2016), 3 descendants of its own
- K221476: Perifit (2023), 2 descendants of its own
- K231780: Perifit Care+ (2023), 1 descendant of its own
- K252748: Pelvic Floor Exerciser (PF01) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K002617
Methodology: https://510kreport.com/methodology