FLN · Class II · 21 CFR 880.2420

FDA Product Code FLN: Monitor, Electric For Gravity Flow Infusion Systems

Leading manufacturers include Imed Corp., Travenol Laboratories, S.A. and Integrated Sensing Systems, Inc..

39
Total
39
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Monitor, Electric For Gravity Flow Infusion Systems Devices (Product Code FLN)

39 devices
1–24 of 39
Cleared May 25, 2018
DripAssist Plus
K172242
Shift Labs, Inc.
General Hospital · 303d
Cleared Oct 13, 2015
DripAssist
K150687
Shift Labs
General Hospital · 210d
Cleared Apr 24, 2014
FLUID LEVEL MONITOR
K133870
Coleman Laboratories
General Hospital · 125d
Cleared Apr 17, 2008
LOW FLUID ALARM
K080704
Em-Tec GmbH
General Hospital · 36d
Cleared Feb 22, 2006
ISSYS DRUG FLOW MONITOR
K050783
Integrated Sensing Systems, Inc.
General Hospital · 331d
Cleared Feb 14, 2006
LEVELERT II FLUID LEVEL SENSOR
K060123
Smith & Nephew, Inc.
General Hospital · 27d
Cleared Apr 07, 2003
DRIP ALERT
K030136
Drip Alert, Inc.
General Hospital · 83d
Cleared Aug 06, 2002
STRYKER L3 HYDROLERT
K022248
Stryker Endoscopy
General Hospital · 25d
Cleared Oct 15, 2001
MT ALERT INFUSION MONITOR
K013121
Sierra Biosearch, Inc.
General Hospital · 27d
Cleared Nov 20, 1997
FLUID CENTURION (4-100-00)
K973025
Northgate Technologies, Inc.
General Hospital · 98d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084
Alexander Mfg. Co.
General Hospital · 29d
Cleared May 26, 1993
AC-901 I.V. INFUSION DROP COUNTER
K923561
Lamtic, Inc.
General Hospital · 313d
Cleared Oct 03, 1991
BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)
K910323
Uab Research Foundation
General Hospital · 252d
Cleared Oct 01, 1990
DRIPTROL
K902808
Trans-Pacific Healthcare-USA
General Hospital · 96d
Cleared Aug 30, 1990
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193
Smith & Nephew Dyonics, Inc.
General Hospital · 42d
Cleared Oct 27, 1989
H.U. I.V. DROP COUNTER
K893693
Li-Lien Corp.
General Hospital · 164d
Cleared Jan 09, 1986
IV MATE
K853843
Medtech Intl., Inc.
General Hospital · 115d
Cleared Nov 12, 1985
MCGAW/DROP WATCH FLOW MONITOR
K853549
American Mcgaw
General Hospital · 78d
Cleared Jun 27, 1985
INFUSAFE 205 CATOLOG NO. 205.000
K852433
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 17d
Cleared Apr 04, 1985
TRAVENOL FLO-GARD 500 IV MONITOR
K850710
Travenol Laboratories, S.A.
General Hospital · 41d
Cleared Jan 22, 1985
INFUSART
K844227
Sartorius, Inc.
General Hospital · 82d
Cleared Jan 22, 1985
IV RATEMETER
K844309
Aci Medical, Inc.
General Hospital · 77d
Cleared Jan 14, 1985
KHM 2000 DRIP WATCHER
K844556
The Timeter Group
General Hospital · 54d
Cleared Jul 12, 1983
DROP RATE COUNTER #340
K831596
Imed Corp.
General Hospital · 56d

About Product Code FLN - Regulatory Context