# K142399: DualCap IV Pole Strips (Disinfectant Caps for Male Luers)

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Connections, Inc.
- Decided: Nov 19, 2014 after 84 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
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. The FDA summary names no predicate by number.

## Indications for use
The Dark Blue DualCap® intended for use on male luer connectors, will disinfect and decontaminate male luer connectors and act as a barrier to contamination between uses: The Dark Blue DualCap® will disinfect the connectors within five (5) minutes after application and act as physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. When left in place for five (5) minutes, the Dark Blue DualCap® disinfects and 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/K142399
Methodology: https://510kreport.com/methodology