# K971293: Lifeshield Primary I.V. Set with Backcheck Valve

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: Jun 27, 1997 after 81 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K033576: Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure (2003), 0 descendants of its own

## Recalls of this device
- Jun 9, 2003 · Not classified · Z-0957-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

## Indications for use
The Primary .V. Set with Backcheck Valve is used for the delivery of 1.V. fluids through the primary line or through the attachment of a secondary line iriio the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.

Source page: https://510kreport.com/device/K971293
Methodology: https://510kreport.com/methodology