# K102405: Infusion Set for Powerpicc Solo 2 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 21, 2011 after 331 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980992 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980992: IV Administration Sets with Needleless Access Devices, Venetec Intl., Inc. (1998) Summary page 1.

## Indications for use
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bards proximally valved catheters. The extension set will connect the IV administration set to the catheter.

Source page: https://510kreport.com/device/K102405
Methodology: https://510kreport.com/methodology