# K111992: Curos Port Protector

- Pathway: 510(k) (Traditional)
- Applicant: Ivera Medical, Inc.
- Decided: Jan 12, 2012 after 183 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.
6 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080466: Alcohol Pad, 122 Corporation (2008) Summary page 5.
- K083508: Swabcap, Excelsior Medical Corp. (2009) Summary page 5.
- K110826: Curos Port Protector, Ivera Medical (2011) Summary page 6.

## Most influential descendants
- K193190: BD PureHub Disinfecting Cap (2020), 1 descendant of its own
- K251592: SteriHub™ Disinfecting Device and Protective Cover (2026), 0 descendants of its own
- K223914: ACTIV™ Cap (2024), 0 descendants of its own
- K200299: Curos Jet Disinfecting Cap (2020), 0 descendants of its own
- K140657: Curos Red Port Protector (2014), 0 descendants of its own

## Indications for use
The Curos is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos ™ will disinfect the valve three (3) minutes after application and act as a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos Protectors were tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, Candlda glibrata, Candida albicans and was found to have >4 log reductlon The Curos Port Protector may be used in the home or healthcare facility.

Source page: https://510kreport.com/device/K111992
Methodology: https://510kreport.com/methodology