# K123065: Catheter Connections Dualcap Solo

- Pathway: 510(k) (Special)
- Applicant: Catheter Connections, Inc.
- Decided: Dec 14, 2012 after 74 days
- Product code: QBP (Cap, Device Disinfectant)
- 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: 6 generations back to K030467 (2003). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113842: Catheter Connections' Dualcap Solo, Catheter Connections, Inc. (2012) Summary page 5.

## Most influential descendants
- K192382: CapKlenZ (2020), 0 descendants of its own

## Recalls of this device
- Aug 5, 2014 · Class II · Z-2595-2014: Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

## Indications for use
When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; 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/K123065
Methodology: https://510kreport.com/methodology