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Accuryn UO/T, Smart Cath Kit
POTRERO MEDICAL, INC. · Model FGS-06-UOT.SMCS · UDI-DI 00868475000280
EXY
Prescription
10
510(k) clearances
2
Adverse events
2
Recalls
43
Facilities
Description
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
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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