# K093229: Catheter Connections Dualcap

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Connections, Inc.
- Decided: Apr 8, 2010 after 176 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: 4 generations back to K030467 (2003). 7 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083508: Swabcap, Excelsior Medical Corp. (2009) Summary page 5.
- K080579: Effectiv (TM) Cap, Hospira, Inc. (2008) Summary page 6.
- K080466: Alcohol Pad, 122 Corporation (2008) Summary page 6.
- K833182: Aplicare Alcohol Prep Pad, Aplicare, Inc. (1983) Summary page 6.
- K981318: Dual Luer Lock Cap, Baxter Healthcare Corp (1998) Summary page 6.

## Most influential descendants
- K113842: Catheter Connections' Dualcap Solo (2012), 2 descendants of its own
- K142806: DualCap (2015), 1 descendant of its own
- K123065: Catheter Connections Dualcap Solo (2012), 1 descendant of its own
- K192382: CapKlenZ (2020), 0 descendants of its own
- K151620: Firefly Peritoneal Dialysis Connector Disinfection System (2016), 0 descendants of its own

## Indications for use
When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; 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/K093229
Methodology: https://510kreport.com/methodology