# K172653: Power Infuser

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Jul 18, 2018 after 316 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820159 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090736: Power Infuser, Model M100B-3A, ZOLL Medical Corporation (2009) Summary page 4.

## Indications for use
The Power Infuser® is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical, paramedical and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood. The device is not intended to support the delivery of any pharmaceutical or other medications.

Source page: https://510kreport.com/device/K172653
Methodology: https://510kreport.com/methodology