# K191362: LifeFlow Blood System

- Pathway: 510(k) (Traditional)
- Applicant: 410 Medical, Inc.
- Decided: May 20, 2020 after 364 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: 6 generations back to K904518 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153731: LifeFlow Rapid Infusion Device (LifeFlow Device), 410 Medical Innovation, LLC (2016) Summary page 4.

## Indications for use
The LifeFlow® Blood System is an intravenous administration set that is intended for the rapid* delivery of blood, blood components (red blood cells or plasma), and crystalloid and colloid resuscitative fluids from a container to a patient’s vascular system. These devices may be used for any adult or pediatric patient, greater than 28 days old and greater than 3kg, with consideration given to adequacy of vascular anatomy, appropriateness for the solution being infused, and duration of therapy. The delivery of blood products is intended for patients requiring volume replacement for hemorrhagic shock or life-threatening bleeding. *Capable of rates greater than 100ml/min

Source page: https://510kreport.com/device/K191362
Methodology: https://510kreport.com/methodology