# K070718: Modification to: Bodyguard Infusion System

- Pathway: 510(k) (Special)
- Applicant: Caesarea Medical Electronics, Ltd.
- Decided: Apr 13, 2007 after 30 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
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.

## Indications for use
The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments. The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)

Source page: https://510kreport.com/device/K070718
Methodology: https://510kreport.com/methodology