# K062042: Plethora Solutions Sexual Assessment Monitor (Sam)

- Pathway: 510(k) (Traditional)
- Applicant: Plethora Solutions
- Decided: Sep 6, 2006 after 49 days
- Product code: LIL (Monitor, Penile Tumescence)
- Device class: U
- 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 K841202 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841202: Dacomed Rigiscan System, Dacomed Corp. (1984) Summary page 1.
- K941781: Rigiscan Plus Rigidity Assessment System, Dacomed Corp. (1994) Summary page 1.

## Indications for use
The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

Source page: https://510kreport.com/device/K062042
Methodology: https://510kreport.com/methodology