# K946349: Stenodoc

- Pathway: 510(k) (Traditional)
- Applicant: Specs USA, Inc.
- Decided: May 24, 1996 after 511 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K860435 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K860435: Model 500A Vascular Spectrum Analyzer W/CW Doppler, Multigon Industries, Inc. (1986). Our OCR of the scanned summary read K850435, FDA’s number for Sartorius Aquasart SM 40035 - Dialysate Sys (Sartorius Filters, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Multigon 500A Vascular Spectrum Analyzer with Doppler”.

## Most influential descendants
- K971790: Knoll/Midus (Male Impotence Diagnostic Ultrasonic System) (1997), 0 descendants of its own

## Indications for use
Detection and analysis of vascular disease in peripheral vessels. Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.

Source page: https://510kreport.com/device/K946349
Methodology: https://510kreport.com/methodology