# K011317: Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 28, 2001 after 59 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM) (2005), 2 descendants of its own
- K131247: Multibolus II Disposable Pain Management System (2013), 0 descendants of its own
- K060933: Solace Post-Operative Pain Relief Infusion System (2006), 0 descendants of its own
- K051828: Nipro Surefuser Ambulatory Infusion Pump (2005), 0 descendants of its own

## Recalls of this device
- Jun 7, 2013 · Class II · Z-1601-2013: 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

Source page: https://510kreport.com/device/K011317
Methodology: https://510kreport.com/methodology