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Urinary Drainage Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K780134

by Medical Devices Inc.

Identifiers

510(k) Number
K780134 FDA 510(k)
FDA Product Code
FCN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5250 FDA 510(k)
Regulation Number
876.5250 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Urinary Drainage Monitoring System is a device designed for the collection and monitoring of urine from indwelling catheters. It is classified as a Class II medical device under FDA regulation 876.5250 and is intended for use in urinary drainage applications.

This system received FDA 510(k) clearance via the traditional pathway under K780134, with a decision of substantially equivalent. It is supplied as a non-sterile, reusable or single-use system depending on configuration, and is intended for use in clinical settings such as hospitals and urology or gastroenterology departments. Storage and handling should follow manufacturer guidelines, and no MRI safety claims are specified in the provided data.

Frequently asked questions

What is the Urinary Drainage Monitoring System used for?

The Urinary Drainage Monitoring System is designed for the collection and monitoring of urine from indwelling catheters in clinical settings such as hospitals, urology, and gastroenterology departments. It supports urinary drainage applications by allowing healthcare providers to measure and track urine output over time.

Is the Urinary Drainage Monitoring System sterile or non-sterile, and is it reusable or single-use?

The system is supplied as non-sterile and can be configured for either reusable or single-use use, depending on the specific setup. This flexibility allows clinical facilities to choose based on their infection control protocols and workflow needs.

What regulatory pathway was used for the Urinary Drainage Monitoring System, and what was the outcome?

The device received FDA 510(k) clearance through the traditional pathway under submission K780134, with a decision of substantially equivalent (SESE), indicating it is substantially equivalent to a legally marketed predicate device.

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: URINARY DRAINAGE MONITORING SYSTEM (K780134) — FDA 510(k) | Innolitics, Urinary Drainage Monitoring System - Beudamed, FDA Browser - Cleared 510 (K) - URINARY DRAINAGE MONITORING SYSTEM ..., Accuryn Monitoring System® | Potrero Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Devices Inc.
FDA Applicant
Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K780134 24 fields · synced Oct 6, 2026