# K031749: Bodyguard Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Caesarea Medical Electronics, Ltd.
- Decided: Aug 21, 2003 after 77 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.
9 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has 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.

## Most influential descendants
- K082182: AP 34 Multi-Therapy Infusion Pump (2008), 8 descendants of its own
- 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
- K192860: Sapphire Infusion Pump, Sapphire administration sets (2020), 1 descendant of its own

## Recalls of this device
- Jan 14, 2020 · Class II · Z-1886-2020: The filter installed onto the tube set may have the incorrect pore size.

## Indications for use
The BodyGucrrd 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 BodyGuul-d Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)

Source page: https://510kreport.com/device/K031749
Methodology: https://510kreport.com/methodology