# K841257: Sta-Potent System

- Pathway: 510(k) (Traditional)
- Applicant: Nu-Potent
- Decided: May 2, 1984 after 37 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 8 cite it directly.
0 of 11 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
- K974173: Erecaid System/Stay Erec System (1998), 3 descendants of its own
- K981506: Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev) (1998), 2 descendants of its own
- K981357: Erco-Vac (1998), 1 descendant of its own
- K981343: Erco-Ribbon (1998), 1 descendant of its own
- K032776: Vacurect Vacuum Constriction Device (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K841257
Methodology: https://510kreport.com/methodology