Uritron Urine Meter
by Joseph F. Daniel, C.R.N.A. 510(k)
Active
510(k) K790894
Overview
The Uritron Urine Meter is a non-electrical, disposable device classified as a urine flow rate measuring instrument. It is designed to quantify and measure the rate of urine flow, providing clinical data for assessment in urological and gastroenterological evaluations. This device aids in diagnosing and monitoring conditions related to urinary function by offering precise measurements during voiding studies.
The Uritron Urine Meter is supplied as a single-use, non-reusable device and is intended for use in clinical settings. It is not specified as MRI-safe or unsafe, and no regulatory approval beyond the FDA 510(k) clearance (K790894) is mentioned. The device falls under the product code FFG and is regulated under the FDA’s classification for Class II medical devices (regulation number 876.1800). Storage and handling instructions are not provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790894 | Date7 Sep 1979 | 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- Withdrawn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
- FFG
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1800
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Uritron Urine Meter used for?
The Uritron Urine Meter is designed to quantify and measure the rate of urine flow during voiding studies. This provides critical clinical data for diagnosing and monitoring conditions related to urinary function, particularly in urological and gastroenterological evaluations. By offering precise measurements, it helps clinicians assess urinary function accurately.
Is the Uritron Urine Meter reusable or single-use?
The Uritron Urine Meter is explicitly intended for single-use only. It is classified as a disposable device, meaning each unit is meant to be used once and then discarded. This design ensures hygiene and prevents cross-contamination in clinical settings.
What are the key specifications for storage and handling?
The provided specifications do not include explicit storage or handling instructions for the Uritron Urine Meter. As a single-use, disposable device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Always follow standard medical device storage protocols unless manufacturer-specific guidelines are provided.
Does the Uritron Urine Meter require any special regulatory approvals?
The Uritron Urine Meter holds an FDA 510(k) clearance with the reference number K790894. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and is regulated under FDA’s Class II medical device category (regulation number 876.1800). No additional regulatory approvals beyond this are mentioned.
What medical specialties benefit most from using the Uritron Urine Meter?
The Uritron Urine Meter is particularly useful in the specialties of gastroenterology and urology. It aids in evaluating urinary function, which is essential for diagnosing and monitoring conditions such as urinary tract obstructions, bladder dysfunction, or other voiding disorders. Clinicians in these fields rely on precise urine flow measurements for accurate patient assessments.