# K050324: Infpump Infiltration Pump

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Medical, Inc.
- Decided: Apr 27, 2005 after 77 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991437 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040149: Psi-Tec Peristaltic Infiltration Pump, Byron Medical (2004) Summary page 2.
- K031432: Klein Surgical Infiltration Pump, Model Kip-II, Hk Surgical, Inc. (2003) Summary page 2.

## Indications for use
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.

Source page: https://510kreport.com/device/K050324
Methodology: https://510kreport.com/methodology