Product code FLN— General Hospital
AC-901 I.V. INFUSION DROP COUNTER
- Classification name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device class
- Class 2
- Regulation
- 21 CFR 880.2420
- Advisory panel
- General Hospital
- Total cleared
- 39
- First cleared
- Most recent
Market context for product code FLN
FDA has cleared devices under product code FLN between 1976 and 2018, filed by 35 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 2015
- 2014
- 2008
- 2006
- 2003
- 2002
- 2001
- 1997
- 1993
- 1991
- 1990
- 1989
- 1986
- 1985
Top applicants under product code FLN
Recent clearances under product code FLN
- K172242 — DripAssist Plus
- K150687 — DripAssist
- K133870 — FLUID LEVEL MONITOR
- K080704 — LOW FLUID ALARM
- K050783 — ISSYS DRUG FLOW MONITOR
- K060123 — LEVELERT II FLUID LEVEL SENSOR
- K030136 — DRIP ALERT
- K022248 — STRYKER L3 HYDROLERT
- K013121 — MT ALERT INFUSION MONITOR
- K973025 — FLUID CENTURION (4-100-00)
- K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
- K923561 — AC-901 I.V. INFUSION DROP COUNTER
- K910323 — BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)
- K902808 — DRIPTROL
- K903193 — SMITH & NEPHEW DYONICS LEVELERT SYSTEM
- K893693 — H.U. I.V. DROP COUNTER
- K853843 — IV MATE
- K853549 — MCGAW/DROP WATCH FLOW MONITOR
- K852433 — INFUSAFE 205 CATOLOG NO. 205.000
- K850710 — TRAVENOL FLO-GARD 500 IV MONITOR
- K844227 — INFUSART
- K844309 — IV RATEMETER
- K844556 — KHM 2000 DRIP WATCHER
- K831596 — DROP RATE COUNTER #340
- K823018 — MODEL 460 INTERMITTENT MEDICATION DELIV
- K821823 — I.V. SENTINEL
- K802166 — MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
- K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
- K801734 — IMED DROP RATE CALCULATOR #340
- K802101 — I.V. SENTRY ALARM DEVICE
- K790836 — GUARDIAN II I.V. CONTROLLER
- K790669 — DROP CONTROLLER
- K781589 — VOLUMETRIC CONTROLLER MODEL 310
- K781717 — MONITOR, GRAVITY IRRIGATION DRIP
- K781297 — INTRA-ALERT
- K780223 — PARENTERAL INFUSION CONTROLLER
- K780106 — PARENTERAL INFUSION CONTROLLER, ELEC.
- K760931 — I.V. DRIP MONITOR ALARM DEVICE, MONIFLO
- K760694 — ARNCO I.V. MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.