Home / 510(k) Clearances / K013121

510(k) K013121

MT ALERT INFUSION MONITOR by Sierra Biosearch, Inc. — Product Code FLN

K013121 is an FDA 510(k) premarket notification submitted by Sierra Biosearch, Inc. for the device "MT ALERT INFUSION MONITOR". The FDA issued a decision of Substantially Equivalent on October 15, 2001. 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
October 15, 2001
Date Received
September 18, 2001
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)
  • K030136 — DRIP ALERT (April 7, 2003)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)
  • K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (July 3, 1997)

FDA data resources