# K061676: Rigidometer, Model Dir-4U

- Pathway: 510(k) (Traditional)
- Applicant: Uroan 21
- Decided: Dec 27, 2006 after 196 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 K000194 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000194: Digital Inflection Rigidometer (Dir), Uroan Xxi Electromedicina (2000)

## Indications for use
The Uroan DIR-4U Rigidometer measures penile axial rigidity.

Source page: https://510kreport.com/device/K061676
Methodology: https://510kreport.com/methodology