# K980627: Neva System

- Pathway: 510(k) (Traditional)
- Applicant: Urometrics, Inc.
- Decided: Apr 7, 1998 after 48 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 K941781 (1994). 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)
- K941781: Rigiscan Plus Rigidity Assessment System, Dacomed Corp. (1994) Summary page 2.

## Indications for use
Measure and record penile erectile events nocturnally

Source page: https://510kreport.com/device/K980627
Methodology: https://510kreport.com/methodology