# K904646: Bci-100 Fecal Incontinence System

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Intl.
- Decided: Mar 19, 1991 after 159 days
- Product code: FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device)
- Device class: 2
- Regulation: 21 CFR 876.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014216: Secca System (2002), 5 descendants of its own
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own
- K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K904646
Methodology: https://510kreport.com/methodology