# K153731: LifeFlow Rapid Infusion Device (LifeFlow Device)

- Pathway: 510(k) (Traditional)
- Applicant: 410 Medical Innovation, LLC
- Decided: Aug 25, 2016 after 241 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: 5 generations back to K904518 (1990). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140838: IV Administration Set with Hand Pump, B.Braun Medical, Inc. (2014) Summary page 4.

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

## Indications for use
The LifeFlow™ Rapid Infusion Device is an intravenous administration set with Handle intended for rapid* delivery of fluids from a container into a patient’s vascular system. The device is intended to deliver only crystalloid and colloid resuscitative fluids. These devices may be used for any pediatric or adult patient population with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused and duration of therapy. *Capable of rates greater than 150 mL/min through a 20G needle.

Source page: https://510kreport.com/device/K153731
Methodology: https://510kreport.com/methodology