# K030002: Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap Port; Lifeshield LF Macrobore Ext.

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jan 27, 2003 after 25 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
5 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101677: Hospira Infusion Blood Sets (2010), 30 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
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1385-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1365-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1377-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1335-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1346-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1381-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1369-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1334-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1328-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1375-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1373-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1347-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1372-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1374-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1376-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1380-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1386-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1348-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1366-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1371-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1370-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1367-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1379-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1362-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1378-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1363-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1332-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1368-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1361-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

## Indications for use
For administration of I.V. fluids from a container to a patient’s vascular system. The safety feature of this device aids in the prevention of needlestick injuries.

Source page: https://510kreport.com/device/K030002
Methodology: https://510kreport.com/methodology