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Stream Dx

ZIEN MEDICAL TECHNOLOGIES, INC. · Model SDX01 · UDI-DI 00860412001503

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use. Stream Dx will calculate a patient's flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx. The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.

Recalls

Date	Firm	Reason
2026-05-29	Emano Metrics, Inc.	Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validat
2022-04-21	Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)	Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower uri

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.