# K121171: Curos Tip

- Pathway: 510(k) (Traditional)
- Applicant: Ivera Medical, Inc.
- Decided: Nov 26, 2012 after 223 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). 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)
- K111992: Curos Port Protector, Ivera Medical, Inc. (2012) Summary page 5.
- K093229: Catheter Connections Dualcap, Catheter Connections, Inc. (2010) Summary page 5.

## Indications for use
The Curos Tips™ are intended for use as a disinfecting cleaner for male luer connectors. Curos Tips will disinfect the male luer (3) minutes after application and will cover the luer until removed. The effectiveness of the Curos Tips was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Tips may be used in the home or healthcare facility.

Source page: https://510kreport.com/device/K121171
Methodology: https://510kreport.com/methodology