# K251592: SteriHub™ Disinfecting Device and Protective Cover

- Pathway: 510(k) (Traditional)
- Applicant: 1World Vista Medical
- Decided: Feb 11, 2026 after 264 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: 6 generations back to K030467 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193190: BD PureHub Disinfecting Cap, Becton, Dickinson and Company (2020) Summary page 5.

## Indications for use
The SteriHub TM Disinf ecting Device and Protective Cover is intended for active disinfection of needleless connectors. The SteriHub Disinf ecting Device and Protective Cover provides a physical barrier to contamination for up to 7 days, if not removed. The SteriHub may be used in the home or healthcare facility.

Source page: https://510kreport.com/device/K251592
Methodology: https://510kreport.com/methodology