Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2420](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2420) → FLN — Monitor, Electric For Gravity Flow Infusion Systems # FLN · Monitor, Electric For Gravity Flow Infusion Systems _General Hospital · 21 CFR 880.2420 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN ## Overview - **Product Code:** FLN - **Device Name:** Monitor, Electric For Gravity Flow Infusion Systems - **Regulation:** [21 CFR 880.2420](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2420) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 39) Showing 20 most recent of 39 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K172242](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K172242.md) | DripAssist Plus | Shift Labs, Inc. | May 25, 2018 | SESE | | [K150687](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K150687.md) | DripAssist | Shift Labs | Oct 13, 2015 | SESE | | [K133870](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K133870.md) | FLUID LEVEL MONITOR | Coleman Laboratories | Apr 24, 2014 | SESE | | [K080704](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K080704.md) | LOW FLUID ALARM | Em-Tec GmbH | Apr 17, 2008 | SESE | | [K050783](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K050783.md) | ISSYS DRUG FLOW MONITOR | Integrated Sensing Systems, Inc. | Feb 22, 2006 | SESE | | [K060123](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K060123.md) | LEVELERT II FLUID LEVEL SENSOR | Smith & Nephew, Inc. | Feb 14, 2006 | SESE | | [K030136](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K030136.md) | DRIP ALERT | Drip Alert, Inc. | Apr 7, 2003 | SESE | | [K022248](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K022248.md) | STRYKER L3 HYDROLERT | Stryker Endoscopy | Aug 6, 2002 | SESE | | [K013121](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K013121.md) | MT ALERT INFUSION MONITOR | Sierra Biosearch, Inc. | Oct 15, 2001 | SESE | | [K973025](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K973025.md) | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | Nov 20, 1997 | SESE | | [K972084](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K972084.md) | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | Jul 3, 1997 | SESE | | [K923561](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K923561.md) | AC-901 I.V. INFUSION DROP COUNTER | Lamtic, Inc. | May 26, 1993 | SESE | | [K910323](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K910323.md) | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | Uab Research Foundation | Oct 3, 1991 | SESE | | [K902808](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K902808.md) | DRIPTROL | Trans-Pacific Healthcare-USA | Oct 1, 1990 | SESE | | [K903193](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K903193.md) | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | Aug 30, 1990 | SESE | | [K893693](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K893693.md) | H.U. I.V. DROP COUNTER | Li-Lien Corp. | Oct 27, 1989 | SESE | | [K853843](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K853843.md) | IV MATE | Medtech Intl., Inc. | Jan 9, 1986 | SESE | | [K853549](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K853549.md) | MCGAW/DROP WATCH FLOW MONITOR | American Mcgaw | Nov 12, 1985 | SESE | | [K852433](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K852433.md) | INFUSAFE 205 CATOLOG NO. 205.000 | Medix Medical Electronics (U.S.A.), Inc. | Jun 27, 1985 | SESE | | [K850710](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN/K850710.md) | TRAVENOL FLO-GARD 500 IV MONITOR | Travenol Laboratories, S.A. | Apr 4, 1985 | SESE | ## Top Applicants - Imed Corp. — 4 clearances - Travenol Laboratories, S.A. — 2 clearances - A.R. Nelson Co., Inc. — 1 clearance - Aci Medical, Inc. — 1 clearance - Alexander Mfg. Co. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLN) **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