# K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Nov 2, 2005 after 34 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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: 1 generation back to K912103 (1991). 1 ancestor in all.
21 later devices descend from it; 4 cite it directly.
4 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912103: Lifeshield Extension Set, Abbott Laboratories (1991) Summary page 1.

## Most influential descendants
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal (2012), 19 descendants of its own
- 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
- K142974: Extension Sets (2015), 4 descendants of its own
- K142367: Hospira Primary Sets (2014), 4 descendants of its own

## Recalls of this device
- Jan 8, 2010 · Not classified · Z-0809-2010: There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.

## Indications for use
The LifeShield® Latex-Free Microbore Extension Set is intended for the delivery of fluids from a container to a patient's vascular system.

Source page: https://510kreport.com/device/K052722
Methodology: https://510kreport.com/methodology