# K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series)

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Apr 24, 2026 after 452 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 5.

## 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/K250234
Methodology: https://510kreport.com/methodology