Atlas FDA

FLN

39 FDA 510(k) clearances · Product code

72 daysmedian time to decision
252 days90th percentile
39clearances measured

FDA profile

Official device name
Monitor, Electric For Gravity Flow Infusion Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2420
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DripAssist Plus (K172242)Shift Labs, Inc.2018-05-25
DripAssist (K150687)Shift Labs2015-10-13
FLUID LEVEL MONITOR (K133870)Coleman Laboratories2014-04-24
LOW FLUID ALARM (K080704)Em-Tec GmbH2008-04-17
ISSYS DRUG FLOW MONITOR (K050783)Integrated Sensing Systems, Inc.2006-02-22
LEVELERT II FLUID LEVEL SENSOR (K060123)Smith & Nephew, Inc.2006-02-14
DRIP ALERT (K030136)Drip Alert, Inc.2003-04-07
STRYKER L3 HYDROLERT (K022248)Stryker Endoscopy2002-08-06
MT ALERT INFUSION MONITOR (K013121)Sierra Biosearch, Inc.2001-10-15
FLUID CENTURION (4-100-00) (K973025)Northgate Technologies, Inc.1997-11-20
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (K972084)Alexander Mfg. Co.1997-07-03
AC-901 I.V. INFUSION DROP COUNTER (K923561)Lamtic, Inc.1993-05-26
BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) (K910323)Uab Research Foundation1991-10-03
DRIPTROL (K902808)Trans-Pacific Healthcare-USA1990-10-01
SMITH & NEPHEW DYONICS LEVELERT SYSTEM (K903193)Smith & Nephew Dyonics, Inc.1990-08-30
H.U. I.V. DROP COUNTER (K893693)Li-Lien Corp.1989-10-27
IV MATE (K853843)Medtech Intl., Inc.1986-01-09
MCGAW/DROP WATCH FLOW MONITOR (K853549)American Mcgaw1985-11-12
INFUSAFE 205 CATOLOG NO. 205.000 (K852433)Medix Medical Electronics (U.S.A.), Inc.1985-06-27
TRAVENOL FLO-GARD 500 IV MONITOR (K850710)Travenol Laboratories, S.A.1985-04-04
INFUSART (K844227)Sartorius, Inc.1985-01-22
IV RATEMETER (K844309)Aci Medical, Inc.1985-01-22
KHM 2000 DRIP WATCHER (K844556)The Timeter Group1985-01-14
DROP RATE COUNTER #340 (K831596)Imed Corp.1983-07-12
MODEL 460 INTERMITTENT MEDICATION DELIV (K823018)Y1983-01-26
I.V. SENTINEL (K821823)The John Bunn Co.1982-08-16
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP (K802166)Baxter Healthcare Corp1980-11-12
INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (K802011)Pollak (Intl.), Ltd.1980-10-31
IMED DROP RATE CALCULATOR #340 (K801734)Imed Corp.1980-10-23
I.V. SENTRY ALARM DEVICE (K802101)Pike Medical Co.1980-09-16
GUARDIAN II I.V. CONTROLLER (K790836)Centaur Sciences, Inc.1979-07-30
DROP CONTROLLER (K790669)Imed Corp.1979-05-14
VOLUMETRIC CONTROLLER MODEL 310 (K781589)Imed Corp.1978-11-22
MONITOR, GRAVITY IRRIGATION DRIP (K781717)Syntel, Inc.1978-10-27
INTRA-ALERT (K781297)Pan-Tech Research, Inc.1978-10-25
PARENTERAL INFUSION CONTROLLER (K780223)Travenol Laboratories, S.A.1978-04-10
PARENTERAL INFUSION CONTROLLER, ELEC. (K780106)National Patent Development Corp.1978-02-21
I.V. DRIP MONITOR ALARM DEVICE, MONIFLO (K760931)Diemolding Corp.1977-01-05
ARNCO I.V. MONITOR (K760694)A.R. Nelson Co., Inc.1976-12-23

Track FLN automatically

Every clearance here is in the API, with alerts when new ones post.