# K151650: SMARTez elastomeric infusion pump

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Apr 4, 2016 after 291 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: 11 generations back to K896422 (1990). 47 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052117: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump), I-Flow Corp. (2005) Summary page 5.
- K071222: Infusor SV and LV Elastomeric Infusion Devices, Baxter Healthcare Corp (2007) Summary page 5.
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump, Westmed, Inc. (2008) Summary page 5.
- K991513: Homepump C-Series and Homepump C-Series One-Step Kvo, I-Flow Corp. (1999) Summary page 5.

## Most influential descendants
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (2026), 0 descendants of its own
- K240624: InfuLife (2024), 0 descendants of its own
- K242152: SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (2024), 0 descendants of its own

## Indications for use
The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management. * Routes of administration: intravenous and subcutaneous. The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery. * Route of administration: intravenous. The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications. * Routes of administration: intravenous and intra-arterial.

Source page: https://510kreport.com/device/K151650
Methodology: https://510kreport.com/methodology