# K992044: Infusion Dynamics Power Infuser Model M100B

- Pathway: 510(k) (Traditional)
- Applicant: Infusion Dynamics, Inc.
- Decided: Sep 8, 1999 after 83 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 21, 2004 · Not classified · Z-0062-05: Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.

## Indications for use
The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in-patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock. The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments. The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

Source page: https://510kreport.com/device/K992044
Methodology: https://510kreport.com/methodology