# K891774: Contimed II Biofeedback Dev Treat of Urin Inconti

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Aug 23, 1989 after 152 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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
- K013653: Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (2002), 5 descendants of its own
- K133990: Ieva Rehabilitative Positional Device (2014), 4 descendants of its own
- K180637: leva Pelvic Floor Trainer (2018), 3 descendants of its own
- K192270: LEva Pelvic Digital Health System (2019), 2 descendants of its own
- K212495: Leva Pelvic Health System (2021), 1 descendant of its own

Source page: https://510kreport.com/device/K891774
Methodology: https://510kreport.com/methodology