# K192382: CapKlenZ

- Pathway: 510(k) (Traditional)
- Applicant: Star Mountain Medical, Inc.
- Decided: Apr 20, 2020 after 234 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: 7 generations back to K030467 (2003). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123065: Catheter Connections Dualcap Solo, Catheter Connections, Inc. (2012) Summary page 4.

## Indications for use
When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.

Source page: https://510kreport.com/device/K192382
Methodology: https://510kreport.com/methodology