# K941214: Lifeshield Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: Oct 3, 1994 after 207 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
4 of 21 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
- 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
- Feb 19, 2013 · Class II · Z-1016-2017: Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of
- Nov 24, 2009 · Not classified · Z-1329-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Sep 29, 2005 · Not classified · Z-0133-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0134-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Sep 29, 2005 · Not classified · Z-0135-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- May 6, 2005 · Not classified · Z-0195-06: Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Jun 9, 2003 · Not classified · Z-0956-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0955-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0958-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- May 13, 2003 · Not classified · Z-0936-03: The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

Source page: https://510kreport.com/device/K941214
Methodology: https://510kreport.com/methodology