# K002380: Infusor SV, Infusor LV, Baxter Pain Management System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 5, 2000 after 32 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041738: Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume) (2004), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K002380
Methodology: https://510kreport.com/methodology