# K021480: Extension Set Light-Safe, Model BC565

- Pathway: 510(k) (Traditional)
- Applicant: Codan US Corp.
- Decided: Jun 27, 2002 after 50 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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.
1 of 12 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
- K041490: IV Administration Sets with Ultrablock UV-Resistant Tubing (2004), 9 descendants of its own
- 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

## Indications for use
The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Source page: https://510kreport.com/device/K021480
Methodology: https://510kreport.com/methodology