FLN · Monitor, Electric For Gravity Flow Infusion Systems
General Hospital · 21 CFR 880.2420 · Class 2
Overview
| Product Code | FLN |
|---|---|
| Device Name | Monitor, Electric For Gravity Flow Infusion Systems |
| Regulation | 21 CFR 880.2420 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | DripAssist Plus | Shift Labs, Inc. | May 25, 2018 | SESE |
| K150687 | DripAssist | Shift Labs | Oct 13, 2015 | SESE |
| K133870 | FLUID LEVEL MONITOR | Coleman Laboratories | Apr 24, 2014 | SESE |
| K080704 | LOW FLUID ALARM | Em-Tec GmbH | Apr 17, 2008 | SESE |
| K050783 | ISSYS DRUG FLOW MONITOR | Integrated Sensing Systems, Inc. | Feb 22, 2006 | SESE |
| K060123 | LEVELERT II FLUID LEVEL SENSOR | Smith & Nephew, Inc. | Feb 14, 2006 | SESE |
| K030136 | DRIP ALERT | Drip Alert, Inc. | Apr 7, 2003 | SESE |
| K022248 | STRYKER L3 HYDROLERT | Stryker Endoscopy | Aug 6, 2002 | SESE |
| K013121 | MT ALERT INFUSION MONITOR | Sierra Biosearch, Inc. | Oct 15, 2001 | SESE |
| K973025 | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | Nov 20, 1997 | SESE |
| K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | Jul 3, 1997 | SESE |
| K923561 | AC-901 I.V. INFUSION DROP COUNTER | Lamtic, Inc. | May 26, 1993 | SESE |
| K910323 | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | Uab Research Foundation | Oct 3, 1991 | SESE |
| K902808 | DRIPTROL | Trans-Pacific Healthcare-USA | Oct 1, 1990 | SESE |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | Aug 30, 1990 | SESE |
| K893693 | H.U. I.V. DROP COUNTER | Li-Lien Corp. | Oct 27, 1989 | SESE |
| K853843 | IV MATE | Medtech Intl., Inc. | Jan 9, 1986 | SESE |
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | American Mcgaw | Nov 12, 1985 | SESE |
| K852433 | INFUSAFE 205 CATOLOG NO. 205.000 | Medix Medical Electronics (U.S.A.), Inc. | Jun 27, 1985 | SESE |
| K850710 | 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
