Cleared Traditional

InfuLife

K240624 · First Medical Source, LLC · General Hospital

Nov 2024

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K240624 is an FDA 510(k) clearance for the InfuLife, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by First Medical Source, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on November 5, 2024, 245 days after receiving the submission on March 5, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K240624 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2024
Decision Date	November 05, 2024
Days to Decision	245 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF