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) → EXY — Uroflowmeter # EXY · Uroflowmeter _Gastroenterology, Urology · 21 CFR 876.1800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY ## Overview - **Product Code:** EXY - **Device Name:** Uroflowmeter - **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 (16 of 16) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K142425](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K142425.md) | Uroflowmeter | Be Technologies, Inc. | Oct 27, 2014 | SESE | | [K022721](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K022721.md) | UROPOWER | W.O.M. World of Medicine AG | Aug 26, 2003 | SESE | | [K971913](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K971913.md) | GR100F URINE FLOWMETER | Albyn Medical , Ltd. | Sep 19, 1997 | SESE | | [K953999](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K953999.md) | DANTEC DA CAPO | Dantec Medical, Inc. | Nov 21, 1995 | SESE | | [K951442](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K951442.md) | FLOLAB | Synectics Medical, Inc. | Aug 24, 1995 | SESE | | [K944972](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K944972.md) | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | Mar 8, 1995 | SESE | | [K945495](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K945495.md) | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Fiberoptic Sensor Technlogies, Inc. | Feb 9, 1995 | SESE | | [K941105](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K941105.md) | UORCAP,MODEL NUMBER UDS-UCAP | Laborie Medical Tech, Inc. | May 10, 1994 | SESE | | [K904557](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K904557.md) | MICROFLO | Life-Tech Intl., Inc. | Dec 28, 1990 | SESE | | [K902408](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K902408.md) | DIAGNOSTIC ULTRASOUND UFS 1005 | Diagnostic Ultrasound Corp. | Aug 10, 1990 | SESE | | [K900770](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K900770.md) | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | Jun 8, 1990 | SESE | | [K894968](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K894968.md) | ULTRACOMPACT | Eutectic Electronics, Inc. | Nov 8, 1989 | SESE | | [K880504](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K880504.md) | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Mct Medical, Inc. | Jun 17, 1988 | SESE | | [K873695](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K873695.md) | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | Jan 27, 1988 | SESE | | [K872077](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K872077.md) | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | Aug 27, 1987 | SESE | | [K770897](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY/K770897.md) | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | Jun 3, 1977 | SESE | ## Top Applicants - Life-Tech Intl., Inc. — 3 clearances - Albyn Medical , Ltd. — 1 clearance - Be Technologies, Inc. — 1 clearance - Biodan Medical Systems, Ltd. — 1 clearance - Dantec Medical, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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