Product Code: FLN FDA class 2 21 CFR 880.2420

Monitor, Electric For Gravity Flow Infusion Systems

General Hospital

The Electric Monitor for Gravity Flow Infusion Systems is a device that electronically monitors the flow rate of intravenous fluids delivered by gravity, alerting clinicians to flow disruptions or empty containers. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLN, regulated under 21 CFR 880.2420 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FLN
Device Class: FDA class 2
Regulation Number: 880.2420
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172242	DripAssist Plus	May 25, 2018	Substantially Equivalent	Shift Labs, Inc.
K150687	DripAssist	Oct 13, 2015	Substantially Equivalent	Shift Labs
K133870	FLUID LEVEL MONITOR	Apr 24, 2014	Substantially Equivalent	Coleman Laboratories
K080704	LOW FLUID ALARM	Apr 17, 2008	Substantially Equivalent	Em-Tec GmbH
K050783	ISSYS DRUG FLOW MONITOR	Feb 22, 2006	Substantially Equivalent	Integrated Sensing Systems, Inc.
K060123	LEVELERT II FLUID LEVEL SENSOR	Feb 14, 2006	Substantially Equivalent	Smith & Nephew, Inc.
K030136	DRIP ALERT	Apr 07, 2003	Substantially Equivalent	Drip Alert, Inc.
K022248	STRYKER L3 HYDROLERT	Aug 06, 2002	Substantially Equivalent	Stryker Endoscopy
K013121	MT ALERT INFUSION MONITOR	Oct 15, 2001	Substantially Equivalent	Sierra Biosearch, Inc.
K973025	FLUID CENTURION (4-100-00)	Nov 20, 1997	Substantially Equivalent	Northgate Technologies, Inc.
K972084	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212	Jul 03, 1997	Substantially Equivalent	Alexander Mfg. Co.
K923561	AC-901 I.V. INFUSION DROP COUNTER	May 26, 1993	Substantially Equivalent	Lamtic, Inc.
K910323	BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)	Oct 03, 1991	Substantially Equivalent	Uab Research Foundation
K902808	DRIPTROL	Oct 01, 1990	Substantially Equivalent	Trans-Pacific Healthcare-USA
K903193	SMITH & NEPHEW DYONICS LEVELERT SYSTEM	Aug 30, 1990	Substantially Equivalent	Smith & Nephew Dyonics, Inc.
K893693	H.U. I.V. DROP COUNTER	Oct 27, 1989	Substantially Equivalent	Li-Lien Corp.
K853843	IV MATE	Jan 09, 1986	Substantially Equivalent	Medtech Intl., Inc.
K853549	MCGAW/DROP WATCH FLOW MONITOR	Nov 12, 1985	Substantially Equivalent	American Mcgaw
K852433	INFUSAFE 205 CATOLOG NO. 205.000	Jun 27, 1985	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K850710	TRAVENOL FLO-GARD 500 IV MONITOR	Apr 04, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K844309	IV RATEMETER	Jan 22, 1985	Substantially Equivalent	Aci Medical, Inc.
K844227	INFUSART	Jan 22, 1985	Substantially Equivalent	Sartorius, Inc.
K844556	KHM 2000 DRIP WATCHER	Jan 14, 1985	Substantially Equivalent	The Timeter Group
K831596	DROP RATE COUNTER #340	Jul 12, 1983	Substantially Equivalent	Imed Corp.
K823018	MODEL 460 INTERMITTENT MEDICATION DELIV	Jan 26, 1983	Substantially Equivalent	Y
K821823	I.V. SENTINEL	Aug 16, 1982	Substantially Equivalent	The John Bunn Co.
K802166	MODEL AS* 7B AUTOSYRINGE INFUSION PUMP	Nov 12, 1980	Substantially Equivalent	Baxter Healthcare Corp
K802011	INFUSSION ALARM SYSTEM I.A.S. CAT.#1118	Oct 31, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K801734	IMED DROP RATE CALCULATOR #340	Oct 23, 1980	Substantially Equivalent	Imed Corp.
K802101	I.V. SENTRY ALARM DEVICE	Sep 16, 1980	Substantially Equivalent	Pike Medical Co.
K790836	GUARDIAN II I.V. CONTROLLER	Jul 30, 1979	Substantially Equivalent	Centaur Sciences, Inc.
K790669	DROP CONTROLLER	May 14, 1979	Substantially Equivalent	Imed Corp.
K781589	VOLUMETRIC CONTROLLER MODEL 310	Nov 22, 1978	Substantially Equivalent	Imed Corp.
K781717	MONITOR, GRAVITY IRRIGATION DRIP	Oct 27, 1978	Substantially Equivalent	Syntel, Inc.
K781297	INTRA-ALERT	Oct 25, 1978	Substantially Equivalent	Pan-Tech Research, Inc.
K780223	PARENTERAL INFUSION CONTROLLER	Apr 10, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780106	PARENTERAL INFUSION CONTROLLER, ELEC.	Feb 21, 1978	Substantially Equivalent	National Patent Development Corp.
K760931	I.V. DRIP MONITOR ALARM DEVICE, MONIFLO	Jan 05, 1977	Substantially Equivalent	Diemolding Corp.
K760694	ARNCO I.V. MONITOR	Dec 23, 1976	Substantially Equivalent	A.R. Nelson Co., Inc.