# K013653: Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Mar 5, 2002 after 119 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
Longest line of descent: 1 generation back to K891774 (1989). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891774: Contimed II Biofeedback Dev Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 1.

## Most influential descendants
- 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
- K213913: leva Pelvic Health System (2022), 0 descendants of its own

## Indications for use
The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K013653
Methodology: https://510kreport.com/methodology