Home / 510(k) Clearances / K844309

510(k) K844309

IV RATEMETER by Aci Medical, Inc. — Product Code FLN

K844309 is an FDA 510(k) premarket notification submitted by Aci Medical, Inc. for the device "IV RATEMETER". The FDA issued a decision of Substantially Equivalent on January 22, 1985. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Aci Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1985
Date Received
November 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type

Other clearances by Aci Medical, Inc.

  • K131146 — ARTASSIST AND VENASSIST (February 10, 2014)
  • K942530 — ART-ASSIST MODEL AA-1000 (February 28, 1996)
  • K903894 — VENAPULSE MODELS VP-25 AND VP-50 (April 3, 1991)
  • K903532 — UNNA-SLEEVE(TM) (November 2, 1990)
  • K881291 — AIR PLETHYSMOGRAPH MODEL APG-1000 (October 14, 1988)
  • K861645 — MICRO-TRACHEOSTOMY CARE KIT (May 9, 1986)

Other clearances for product code FLN

  • K172242 — DripAssist Plus (May 25, 2018)
  • K150687 — DripAssist (October 13, 2015)
  • K133870 — FLUID LEVEL MONITOR (April 24, 2014)
  • K080704 — LOW FLUID ALARM (April 17, 2008)
  • K050783 — ISSYS DRUG FLOW MONITOR (February 22, 2006)
  • K060123 — LEVELERT II FLUID LEVEL SENSOR (February 14, 2006)
  • K030136 — DRIP ALERT (April 7, 2003)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K013121 — MT ALERT INFUSION MONITOR (October 15, 2001)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)

FDA data resources