# K041738: Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Jul 9, 2004 after 11 days
- Product code: FRN (Pump, Infusion)
- 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 K002380 (2000). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002380: Infusor SV, Infusor LV, Baxter Pain Management System, Baxter Healthcare Corp (2000) Summary page 1.

## Most influential descendants
- K071222: Infusor SV and LV Elastomeric Infusion Devices (2007), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own
- 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 modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.

Source page: https://510kreport.com/device/K041738
Methodology: https://510kreport.com/methodology