# K060479: Modification to Bodyguard Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Caesarea Medical Electronics, Ltd.
- Decided: May 12, 2006 after 78 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.
11 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K141389: Sapphire Infusion Pump (2014), 3 descendants of its own
- K161667: Sapphire Infusion Pump (2017), 2 descendants of its own
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (2009), 2 descendants of its own
- K192860: Sapphire Infusion Pump, Sapphire administration sets (2020), 1 descendant of its own

## Indications for use
The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.

Source page: https://510kreport.com/device/K060479
Methodology: https://510kreport.com/methodology