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) → FFG — Device, Urine Flow Rate Measuring, Non-Electrical, Disposable # FFG · Device, Urine Flow Rate Measuring, Non-Electrical, Disposable _Gastroenterology, Urology · 21 CFR 876.1800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG ## Overview - **Product Code:** FFG - **Device Name:** Device, Urine Flow Rate Measuring, Non-Electrical, Disposable - **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 (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K893827](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K893827.md) | PEAK FLOW RATE METER | Laytech Medical Co. | Aug 11, 1989 | SESE | | [K883274](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K883274.md) | SURGITEK (R) UROFLOW SYSTEM | Medical Engineering Corp. | Feb 8, 1989 | SESE | | [K850169](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K850169.md) | ERIS URO-DIAGNOSTIC SYSTEM | Eris Medical Technology | Apr 22, 1985 | SESE | | [K844338](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K844338.md) | 1URO-LOG HOME DIAGNOSTIC PACK | Epcom Medical Systems, Inc. | Feb 25, 1985 | SESE | | [K843442](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K843442.md) | URINARY DRAINAGE CONTAINER 2013 WITH | Vital Metrics, Inc. | Jan 3, 1985 | SESE | | [K843441](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K843441.md) | URINARY DRAINAGE CONTAINER 2012-WITH | Vital Metrics, Inc. | Jan 3, 1985 | SESE | | [K844030](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K844030.md) | ACCUMETER ELECTRONIC URINEMETER SYSTEM | Travenol Laboratories, S.A. | Nov 20, 1984 | SESE | | [K843224](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K843224.md) | UROPUMP MODEL 1711 | Life-Tech Intl., Inc. | Oct 19, 1984 | SESE | | [K833043](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K833043.md) | UROMETER | Browne Medical, Inc. | Feb 4, 1984 | SESE | | [K813641](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K813641.md) | VITAL METRICS URINE MONITORING SYSTEM | Vital Metrics, Inc. | Mar 1, 1982 | SESE | | [K813082](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K813082.md) | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | Dec 31, 1981 | SESE | | [K811925](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K811925.md) | UROFLOWMETER | C.R. Bard, Inc. | Sep 8, 1981 | SESE | | [K790894](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K790894.md) | URITRON URINE METER | Joseph F. Daniel, C.R.N.A. | Sep 7, 1979 | SESE | | [K790365](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K790365.md) | FLUID MEASUREMENT STAND | Hewlett-Packard Co. | May 11, 1979 | SESE | | [K790663](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K790663.md) | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | Apr 24, 1979 | SESE | | [K781597](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K781597.md) | PM 2000 AUTOMATIC PATIENT CHAIR | Time Motion System Co. | Sep 27, 1978 | SESE | | [K771655](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG/K771655.md) | CURITY PEAKOMETER | Kendall Research Center | Oct 14, 1977 | SESE | ## Top Applicants - Vital Metrics, Inc. — 3 clearances - Browne Medical, Inc. — 1 clearance - Burron Medical Products, Inc. — 1 clearance - C.R. Bard, Inc. — 1 clearance - Epcom Medical Systems, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com