# K140657: Curos Red Port Protector

- Pathway: 510(k) (Traditional)
- Applicant: Ivera Medical, Inc.
- Decided: Dec 4, 2014 after 265 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.
- K101385: Dual Luer Lock Cap, Model 2C6250, Baxter Healthcare Corp (2010) Summary page 5.

## Indications for use
The Curos Red is intended for use on dialysis catheter female Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The effectiveness of the Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red may be used in the home or healthcare facility.

Source page: https://510kreport.com/device/K140657
Methodology: https://510kreport.com/methodology