# K193190: BD PureHub Disinfecting Cap

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Nov 9, 2020 after 356 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). 8 ancestors in all.
1 later device descends 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)
- K111992: Curos Port Protector, Ivera Medical, Inc. (2012) Summary page 5.

## Most influential descendants
- K251592: SteriHub™ Disinfecting Device and Protective Cover (2026), 0 descendants of its own

## Indications for use
BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

Source page: https://510kreport.com/device/K193190
Methodology: https://510kreport.com/methodology