Home / 510(k) Clearances / K030136

510(k) K030136

DRIP ALERT by Drip Alert, Inc. — Product Code FLN

K030136 is an FDA 510(k) premarket notification submitted by Drip Alert, Inc. for the device "DRIP ALERT". The FDA issued a decision of Substantially Equivalent on April 7, 2003. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2003
Date Received
January 14, 2003
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 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)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K013121 — MT ALERT INFUSION MONITOR (October 15, 2001)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)
  • K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (July 3, 1997)

FDA data resources