# K051828: Nipro Surefuser Ambulatory Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Dec 15, 2005 after 162 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: 1 generation back to K011317 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011317: Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System, Baxter Healthcare Corp (2001)

## Indications for use
The Nipro Surefuser Ambulatory Balloon Infuser is intended fur continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.

Source page: https://510kreport.com/device/K051828
Methodology: https://510kreport.com/methodology