# K953640: Duna II Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Dacomed Corp.
- Decided: Oct 27, 1995 after 84 days
- Product code: FAE (Prosthesis, Penile)
- Device class: 2
- Regulation: 21 CFR 876.3630
- Recalls of this device: 2 (0 Class I)
- 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
- K082006: Ams Spectra Concealable Penile Prosthesis (2008), 1 descendant of its own
- K090663: Ams Spectra Concealable Penile Prosthesis (2009), 0 descendants of its own

## Recalls of this device
- Feb 19, 2007 · Not classified · Z-0702-2007: Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
- Feb 19, 2007 · Not classified · Z-0703-2007: Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

Source page: https://510kreport.com/device/K953640
Methodology: https://510kreport.com/methodology