# K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 15, 2005 after 60 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002739 (2000). 2 ancestors in all.
2 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)
- K011317: Multirate Infusor SV; Multirate Infuser LV; Baxter Pain Mate Pain Management System, Baxter Healthcare Corp (2001)
- K002739: Infusor Patient Control Module, 2ML, Model 2C1067K, Baxter Healthcare Corp (2000) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Apr 17, 2014 · Class II · Z-1536-2015: Potential for device malfunction resulting in flow when the device should not be flowing
- Jun 7, 2013 · Class II · Z-1602-2013: 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

## Indications for use
The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intra-operative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.

Source page: https://510kreport.com/device/K051253
Methodology: https://510kreport.com/methodology