Urinary Monitoring Sys 240
by Vital Metrics, Inc. 510(k)
Active
510(k) K840917
Overview
The Urinary Monitoring System 240 is a Collector, Urine, (and Accessories) For Indwelling Catheter, designed to monitor and collect urine from patients with indwelling catheters. It is intended for use in clinical settings where continuous or periodic urine output assessment is required, such as in urology and gastroenterology procedures. The system facilitates the measurement and documentation of urine volume, aiding in patient management and diagnostic evaluation.
This device is supplied as a reusable system, intended for use in hospital or clinical environments. It is not classified as sterile but is intended for single-patient use per cycle, with proper cleaning and maintenance between uses. The system adheres to FDA regulatory standards under Regulation 876.5250 and holds a 510(k) clearance (K840917) for substantial equivalence. No MRI safety or specific size variations are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840917 | Date1 May 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KNX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5250
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vital Metrics, Inc.
Questions
What is the Urinary Monitoring System 240 used for?
The Urinary Monitoring System 240 is designed to continuously or periodically monitor and collect urine from patients with indwelling catheters. It helps clinicians assess urine output, which is critical for patient management and diagnostic evaluation in specialties like urology and gastroenterology. The system aids in tracking volume trends over time, ensuring timely intervention if abnormalities are detected.
Is the Urinary Monitoring System 240 sterile?
No, the Urinary Monitoring System 240 is not classified as sterile. However, it is intended for single-patient use per cycle, meaning it can be reused for one patient at a time with proper cleaning and maintenance between uses. This design ensures hygiene and reduces cross-contamination risks in hospital or clinical environments.
How is the Urinary Monitoring System 240 supplied and maintained?
The system is supplied as a reusable device, intended for use in hospital or clinical settings. After use with a single patient, it must undergo thorough cleaning and maintenance to prepare it for reuse with another patient. This process adheres to manufacturer guidelines and clinical protocols to ensure safety and functionality. Proper maintenance extends the device’s lifespan and reliability.
Can the Urinary Monitoring System 240 be used in MRI environments?
The regulatory data for the Urinary Monitoring System 240 does not specify MRI safety information. Clinicians should consult the manufacturer’s instructions for use or additional documentation to determine compatibility with MRI environments before use. If MRI exposure is required, alternative monitoring solutions may need to be considered.
What regulatory approval does the Urinary Monitoring System 240 hold?
The Urinary Monitoring System 240 holds a 510(k) clearance from the FDA under the classification of Collector, Urine, (and Accessories) For Indwelling Catheter. The clearance number is K840917, and it is classified under Regulation 876.5250. This approval indicates that the device meets FDA standards for substantial equivalence to a predicate device, ensuring its safety and effectiveness for the intended use.