# K110826: Curos Port Protector

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivera Medical
- Decided: Jun 23, 2011 after 91 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: 2 generations back to K833182 (1983). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- K111992: Curos Port Protector (2012), 6 descendants of its own
- 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

## Indications for use
The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.

Source page: https://510kreport.com/device/K110826
Methodology: https://510kreport.com/methodology