# K061325: Bodygaurd Pain Manager Infusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Caesarea Medical Electronics, Ltd.
- Decided: Aug 24, 2006 after 105 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jan 7, 2020 · Class I · Z-1474-2020: Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected dru

## 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 in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)

Source page: https://510kreport.com/device/K061325
Methodology: https://510kreport.com/methodology