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510(k) K240624

InfuLife by First Medical Source, LLC — Product Code MEB

K240624 is an FDA 510(k) premarket notification submitted by First Medical Source, LLC for the device "InfuLife". The FDA issued a decision of Substantially Equivalent on November 5, 2024. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2024
Date Received
March 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances for product code MEB

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  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)

FDA data resources