# K881321: Blood/Solution Set W/Pressure Pump

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 16, 1988 after 79 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050115: Blood Hand Pump Administration Set (2005), 7 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own
- K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector (2008), 3 descendants of its own
- K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe (2012), 2 descendants of its own

## Recalls of this device
- Jul 16, 2003 · Not classified · Z-1174-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1165-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1173-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Dec 18, 2002 · Not classified · Z-0451-03: Leakage may occur at the inlet port
- Dec 18, 2002 · Not classified · Z-0452-03: Leakage may occur at the inlet port
- Dec 18, 2002 · Not classified · Z-0448-03: Leakage may occur at the inlet port
- Dec 18, 2002 · Not classified · Z-0449-03: Leakage may occur at the inlet port
- Dec 18, 2002 · Not classified · Z-0453-03: Leakage may occur at the inlet port

Source page: https://510kreport.com/device/K881321
Methodology: https://510kreport.com/methodology