FLNClass II
Monitor, Electric For Gravity Flow Infusion Systems
General Hospital · 21 CFR 880.2420
MDR events14All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances39All time
Recent MDR events
14 adverse event reports on file
- OOK SNOW ALLDec 10, 2025InjuryUmano Medical Inc3009591865-2025-00036
- OOK SNOWDec 9, 2025MalfunctionUmano Medical Inc3009591865-2025-00034
- PRO 6000 W/LARGE CRADLEJun 10, 2022MalfunctionWelch Allyn Inc.1316463-2022-00087
- CENTRELLA FRAMEMar 3, 2022MalfunctionHill-rom Batesville1824206-2022-00125
- OOK SNOWDec 10, 2018InjuryUmano Medical Inc3009591865-2018-00021
- LEVELERT II FLUID LEVEL SENSORJan 17, 2017MalfunctionSmith & Nephew, Inc.1643264-2017-00038
- ARGON PATIENT MONITORING SETAug 22, 1997MalfunctionMaxxim Medical, Inc.1625425-1997-00067
- FLOW DETECTORJul 11, 1997InjuryAbbott Laboratories2921482-1997-00122
- ARGONMay 2, 1997InjuryMaxxim Medical89041
- ARGON PATIENT MONITORING SETMay 2, 1997Injury*1625425-1997-90025
Event type breakdown
Malfunction8
Injury6
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
39 clearances for this product code
- Shift Labs, Inc.May 25, 2018
K172242 · DripAssist Plus
- Shift LabsOct 13, 2015
K150687 · DripAssist
- Coleman LaboratoriesApr 24, 2014
K133870 · FLUID LEVEL MONITOR
- Em-Tec GmbHApr 17, 2008
K080704 · LOW FLUID ALARM
- Integrated Sensing Systems, Inc.Feb 22, 2006
K050783 · ISSYS DRUG FLOW MONITOR
- Smith & Nephew, Inc.Feb 14, 2006
K060123 · LEVELERT II FLUID LEVEL SENSOR
- Drip Alert, Inc.Apr 7, 2003
K030136 · DRIP ALERT
- Stryker EndoscopyAug 6, 2002
K022248 · STRYKER L3 HYDROLERT