Identifiers
- 510(k) Number
- K964690 FDA 510(k)
- FDA Product Code
- KNX 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 Liberty Valve is a Collector, Urine, (and Accessories) for Indwelling Catheter, classified as a Class II medical device. It is an electromechanical system designed to facilitate controlled drainage of urine from wheelchair-mounted leg bags. The device incorporates a push-button switch, solenoid valve, fuse, battery leads, and tubing to enable user-activated valve opening for emptying the collection bag, with automatic closure upon deactivation.
The Liberty Valve is permanently mounted to a wheelchair and intended for single-use applications in clinical settings such as hospitals or home care. It operates via a battery-powered solenoid mechanism triggered by the user, ensuring hands-free drainage of indwelling catheter urine collection systems. The device is regulated under FDA 510(k) clearance (K964690) and falls under the regulatory category 876.5250, with no third-party certification indicated. No sterility or MRI safety information is specified in the available data.
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: K964690 FDA 510 (k) - LIBERTY VALVE, PDF K964690 - Liberty Valve, fda.innolitics.com, Liberty Valve - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964690 | Class II | Active |
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Manufacturer
- Manufacturer
- Cleveland Medical Devices Inc.
- FDA Applicant
- Cleveland Medical Devices, Inc.
Sources (1)
- FDA 510(k) K964690 24 fields · synced Oct 1, 2026