# K042431: PROCON2

- Pathway: 510(k) (Traditional)
- Applicant: Incontinent Control Devices, Inc.
- Decided: May 27, 2005 after 261 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K864218 (1987). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864218: Procon, Healthcare Management Systems (1987)

## Most influential descendants
- K122003: Renew Insert (2012), 1 descendant of its own
- K243367: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (2025), 0 descendants of its own

## Indications for use
Procon 2 is a single use catheter with an inflatable balloon cuff intended to act as a barrier to the passage of fecal matter through the rectun. Procon2 is for an individual with fecal incontinence that has impaired quality of life, is sufficiently motivated psychologically to participate in their own treatment, and having good manual dexterity is an ideal candidate. He or she is either not a surgical candidate or has not responded to conservative treatment.

Source page: https://510kreport.com/device/K042431
Methodology: https://510kreport.com/methodology