# K885323: Dacomed External Male Continence Device

- Pathway: 510(k) (Traditional)
- Applicant: Dacomed Corp.
- Decided: Feb 8, 1989 after 42 days
- Product code: FHA (Clamp, Penile)
- Device class: 1
- Regulation: 21 CFR 876.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K974040: C3 External Male Bladder Control Device (1998), 0 descendants of its own
- K971992: Uromed Alternative Bladder Control Continence Device (Abcpn-0026) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K885323
Methodology: https://510kreport.com/methodology