# K031432: Klein Surgical Infiltration Pump, Model Kip-II

- Pathway: 510(k) (Abbreviated)
- Applicant: Hk Surgical, Inc.
- Decided: Aug 7, 2003 after 93 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
No predicates in its family tree.
6 later devices descend from it; 4 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170629: Vitruvian Infiltration Pump (2017), 1 descendant of its own
- K123822: Klein Touch Pump and Disposable Tubing Set (2013), 1 descendant of its own
- K220318: PAL Infiltration System (2022), 0 descendants of its own
- K151255: Navigator Aesthetic Delivery System (2015), 0 descendants of its own
- K050324: Infpump Infiltration Pump (2005), 0 descendants of its own

## Indications for use
This Infiltration Pump is used to cause a flow of fluid from an D/ bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.

Source page: https://510kreport.com/device/K031432
Methodology: https://510kreport.com/methodology