---
kind: "section"
citation: "21 C.F.R. § 876.1800"
title: "21"
number: "876.1800"
heading: "Urine flow or volume measuring system."
url: "https://uscodex.org/cfr/21/876.1800"
---

# §876.1800. Urine flow or volume measuring system.

- (a) **Identification.** A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.
- (b) **Classification.**
  - (1) **Class II (special controls).** The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 876.9](/cfr/21/876.9.md).

## Notes

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, 1998]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, 1998]