# K140838: IV Administration Set with Hand Pump

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Dec 5, 2014 after 247 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 4 generations back to K904518 (1990). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
4 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062700: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2006) Summary page 5.
- K101677: Hospira Infusion Blood Sets, Hospira, Inc. (2010) Summary page 5.
- K050115: Blood Hand Pump Administration Set, Cardinal Health, Alaris Products (2005) Summary page 5.

## Most influential descendants
- 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
- K191362: LifeFlow Blood System (2020), 0 descendants of its own

## Indications for use
The IV Administration Sets with Hand Pump are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. When the hand pump component is activated, the device is intended to deliver only crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Source page: https://510kreport.com/device/K140838
Methodology: https://510kreport.com/methodology