Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1800](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1800) → EXR — Urinometer, Mechanical

# EXR · Urinometer, Mechanical

_Gastroenterology, Urology · 21 CFR 876.1800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR

## Overview

- **Product Code:** EXR
- **Device Name:** Urinometer, Mechanical
- **Regulation:** [21 CFR 876.1800](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1800)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Special Controls

*Classification.* (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K934142](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K934142.md) | URINARY DRAINAGE BAG | Key Medical Services, Inc. | May 17, 1994 | SESE |
| [K935578](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K935578.md) | URINE METER | Puritas Health Care, Inc. | Dec 17, 1993 | SESE |
| [K911258](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K911258.md) | KENDALL PEDIATRIC URINE METER | Kendall Healthcare Products Co. Div.Of Tyco Health | Apr 25, 1991 | SESE |
| [K896732](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K896732.md) | UNOMETER 500 | Unoplast A/S | Nov 2, 1990 | SESE |
| [K870240](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K870240.md) | COMPRESS AND SKULLCAP, HEAD DRESSING | Fraass Survival Systems, Inc. | Feb 20, 1987 | SESE |
| [K771561](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K771561.md) | DOVER URINE METER | Will Ross Co. | Sep 7, 1977 | SESE |
| [K770939](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K770939.md) | URINE TESTER, MODEL 701 | Brother Scientific Products, Inc. | Jun 3, 1977 | SESE |
| [K770423](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K770423.md) | URINE TESTER, MODEL NO. 707 | Brother Scientific Products, Inc. | Jun 3, 1977 | SESE |
| [K761083](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR/K761083.md) | BARD URINE METER W/ BAG | C.R. Bard, Inc. | Jan 26, 1977 | SESE |

## Top Applicants

- Brother Scientific Products, Inc. — 2 clearances
- C.R. Bard, Inc. — 1 clearance
- Fraass Survival Systems, Inc. — 1 clearance
- Kendall Healthcare Products Co. Div.Of Tyco Health — 1 clearance
- Key Medical Services, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXR)

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