# K041490: IV Administration Sets with Ultrablock UV-Resistant Tubing

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 29, 2004 after 147 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021480 (2002). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021480: Extension Set Light-Safe, Model BC565, Codan US Corp. (2002) Summary page 1.
- (no number) Abbott LifeShield® Primary Microbore Device Set: named in the summary without a submission number

## 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
- Nov 24, 2009 · Not classified · Z-0677-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi

## Indications for use
The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

Source page: https://510kreport.com/device/K041490
Methodology: https://510kreport.com/methodology