# K240624: InfuLife

- Pathway: 510(k) (Traditional)
- Applicant: First Medical Source, LLC
- Decided: Nov 5, 2024 after 245 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K896422 (1990). 48 ancestors in all.
No later device cites it as a predicate yet.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151650: SMARTez elastomeric infusion pump, Epic Medical Pte., Ltd. (2016) Summary page 6.

## Indications for use
InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for continuous and/or intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.

Source page: https://510kreport.com/device/K240624
Methodology: https://510kreport.com/methodology