# K042122: Smartinfuser Painpump

- Pathway: 510(k) (Traditional)
- Applicant: Precise Medical Products
- Decided: Sep 22, 2004 after 47 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
Longest line of descent: 3 generations back to K896422 (1990). 5 ancestors in all.
1 later device descends 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)
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 2.

## Most influential descendants
- K061409: Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set (2006), 0 descendants of its own

## 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.

## 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/K042122
Methodology: https://510kreport.com/methodology