# K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Jan 12, 2012 after 28 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 K030467 (2003). 8 ancestors in all.
19 later devices descend from it; 5 cite it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941214: Lifeshield Extension Set, Abbott Mfg., Inc. (1994) Summary page 1.
- K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others, Hospira, Inc. (2005) Summary page 1.
- K101677: Hospira Infusion Blood Sets, Hospira, Inc. (2010) 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
- K142974: Extension Sets (2015), 4 descendants of its own
- K142367: Hospira Primary Sets (2014), 4 descendants of its own
- K143015: Hospira Primary Sets (2015), 3 descendants of its own

## Indications for use
LIFESHIELD VISION Infusion sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.

Source page: https://510kreport.com/device/K113683
Methodology: https://510kreport.com/methodology