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CarePath System

I/O Urology Corp. · Model DCDUFD-001M · UDI-DI 00860010862209

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.

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.