# K971790: Knoll/Midus (Male Impotence Diagnostic Ultrasonic System)

- Pathway: 510(k) (Traditional)
- Applicant: Urometrics, Inc.
- Decided: Dec 17, 1997 after 217 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860435 (1986). 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)
- K946349: Stenodoc, Specs USA, Inc. (1996) Summary page 1.

## Indications for use
Measurement of penile cavernosal artery velocities. Not intended for fetal use.

Source page: https://510kreport.com/device/K971790
Methodology: https://510kreport.com/methodology