# K090736: Power Infuser, Model M100B-3A

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: May 20, 2009 after 62 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: 1 generation back to K820159 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030739: Infusion Dynamics (ID) Power Infuser, Model M100B-3A with Blood Cartridge, Infusion Dynamics, Inc. (2004) Summary page 1.
- K820159: Pressure Infuser, David Clark Company, Inc. (1982) Summary page 2.

## Most influential descendants
- K172653: Power Infuser (2018), 0 descendants of its own

## Indications for use
The Power Infuser® Model M100B-3A 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/K090736
Methodology: https://510kreport.com/methodology