# K123967: Catheter Connections' Dark Blue Dualcap for Male Luers

- Pathway: 510(k) (Special)
- Applicant: Catheter Connections, Inc.
- Decided: Jan 22, 2013 after 27 days
- Product code: QBP (Cap, Device Disinfectant)
- 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
Longest line of descent: 5 generations back to K030467 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093229: Catheter Connections Dualcap, Catheter Connections, Inc. (2010) Summary page 5.

## Indications for use
When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

Source page: https://510kreport.com/device/K123967
Methodology: https://510kreport.com/methodology