# K061409: Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set

- Pathway: 510(k) (Special)
- Applicant: Precise Medical Products, Ltd.
- Decided: Jun 16, 2006 after 25 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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: 4 generations back to K896422 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042122: Smartinfuser Painpump, Precise Medical Products (2004) Summary page 2.

## Recalls of this device
- Mar 17, 2010 · Not classified · Z-1982-2011: Elastomeric tube in product's compression unit has the potential to burst following filling.
- Jan 8, 2009 · Not classified · Z-1021-2010: Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.

## Indications for use
The SmartInfuser PainPump Tm is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.

Source page: https://510kreport.com/device/K061409
Methodology: https://510kreport.com/methodology