# K033576: Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Dec 4, 2003 after 21 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790062 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971293: Lifeshield Primary I.V. Set with Backcheck Valve, Abbott Mfg., Inc. (1997) Summary page 3.
- K790062: IV Administration Set with Backcheck, National Patent Development Corp. (1979) Summary page 2.
- K832755: Infusion Pump & IV Sets #4000, Omni-Glow, Inc. (1983) Summary page 3.
- K882594: The Omni-Flow Therapist Infusion Management System, Omni-Flow, Inc. (1988) Summary page 3.
- K915571: Clave Connector, Icu Medical, Inc. (1992) Summary page 3.
- K944125: Abbott Lte Infusion Pump, Abbott Laboratories (1994) Summary page 3.

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1340-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1384-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1393-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1387-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1382-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1383-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

## Indications for use
The device is used with the Omni-Flow® Medication Management System for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.

Source page: https://510kreport.com/device/K033576
Methodology: https://510kreport.com/methodology