# K912103: Lifeshield Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 13, 1991 after 214 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others (2005), 21 descendants of its own
- 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

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1388-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Jun 9, 2003 · Not classified · Z-0959-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

Source page: https://510kreport.com/device/K912103
Methodology: https://510kreport.com/methodology