Cleared Traditional

K240624 - InfuLife

K240624 is an FDA 510(k) clearance for InfuLife, manufactured by First Medical Source, LLC. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K240624 · First Medical Source, LLC · General Hospital
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Nov 2024
Decision
245d
Days
Class 2
Risk

K240624 is an FDA 510(k) clearance for the InfuLife. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by First Medical Source, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on November 5, 2024 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all First Medical Source, LLC devices

FDA 510(k) Submission Details - K240624

510(k) Number K240624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 33
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K240624.
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234 · Epic Medical Pte. , Ltd. · Apr 2026
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · Epic Medical Pte. , Ltd. · Oct 2024
ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007