# K945611: Peritron

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Design Pty., Ltd.
- Decided: Feb 8, 1996 after 450 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K970077: Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K945611
Methodology: https://510kreport.com/methodology