# K050115: Blood Hand Pump Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Apr 1, 2005 after 73 days
- Product code: BRZ (Set, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881321 (1988). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882302: Ivac (R) Unvented Vol. Infusion Set Model 52080, Y (1988) Summary page 2.
- K881321: Blood/Solution Set W/Pressure Pump, Baxter Healthcare Corp (1988) Summary page 2.

## Most influential descendants
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own
- K153731: LifeFlow Rapid Infusion Device (LifeFlow Device) (2016), 1 descendant of its own
- K213588: Q2 IV Administration Sets (2022), 0 descendants of its own
- K202618: IV Administration Sets (2021), 0 descendants of its own

## Indications for use
A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

Source page: https://510kreport.com/device/K050115
Methodology: https://510kreport.com/methodology