# K103344: Infusion Sets

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Dec 10, 2010 after 25 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: 3 generations back to K011442 (2001). 5 ancestors in all.
10 later devices descend from it; 1 cites it directly.
6 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041550: Hospira Phoenix Infusion System with Hospira Mednet Software, Abbott Laboratories (2004) Summary page 1.

## Most influential descendants
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own
- K223607: Plum Duo™ Infusion System (2023), 2 descendants of its own
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), 2 descendants of its own
- K183311: Ivenix Infusion System (IIS) (2019), 1 descendant of its own

## Indications for use
Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/I Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.

Source page: https://510kreport.com/device/K103344
Methodology: https://510kreport.com/methodology