# K882503: 30 IV Extension Set W/Two Male Luer Locks

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Aug 25, 1988 after 69 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 3, 2017 · Class II · Z-0933-2018: The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containin

Source page: https://510kreport.com/device/K882503
Methodology: https://510kreport.com/methodology