# K071222: Infusor SV and LV Elastomeric Infusion Devices

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: May 25, 2007 after 23 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002380 (2000). 2 ancestors in all.
4 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)
- K041738: Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume), Baxter Healthcare Corporation (2004) Summary page 2.
- K002380: Infusor SV, Infusor LV, Baxter Pain Management System, Baxter Healthcare Corp (2000) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Jun 7, 2013 · Class II · Z-1600-2013: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvemen
- Jul 31, 2009 · Class II · Z-1679-2013: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of l
- Jul 31, 2009 · Class II · Z-1677-2013: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of l
- Jul 31, 2009 · Class II · Z-1678-2013: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of l

## Indications for use
The Infusion Pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management

Source page: https://510kreport.com/device/K071222
Methodology: https://510kreport.com/methodology