Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Acc…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221020

Identifiers

510(k) Number: K221020 FDA 510(k)
FDA Product Code: EZL FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.5130 FDA 510(k)
Regulation Number: 876.5130 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESK Substantially Equivalent — Kit FDA 510(k)

The Accuryn Monitoring System is a retention-type balloon catheter designed for urinary drainage and monitoring of urine output and core body temperature in both Fahrenheit and Celsius. The Accuryn SmartFoley IAP UO Temp variant additionally measures intraabdominal pressure, providing real-time data for clinical assessment.

This system is intended for single-use in clinical settings such as hospitals and urology/gastroenterology departments. Supplied sterile, it includes a nurse-designed insertion tray with catheter fixation and two one-way valves to reduce the risk of catheter-associated urinary tract infections (CAUTI). Available in sizes 12 French and 14 French, the device complies with FDA 510(k) and MDD regulatory standards (K221020, registration number 876.5130).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System ..., Accuryn® Monitoring System - Accuryn, Accuryn SmartFoley IAP UO Temp Tray System 14Fr

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K221020	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Potrero Medical, Inc.

Sources (2)

FDA 510(k) K221020 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026