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SteriHub Disinfecting Device and Protective Cover

by 1World Vista Medical 510(k)

Active United States

510(k) K251592

Overview

The SteriHub Disinfecting Device and Protective Cover is a device disinfectant cap classified under regulation number 880.5440 and product code QBP. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.

The device provides active disinfection of needleless connectors and offers a physical barrier to contamination for up to 7 days if not removed. It may be used in home or healthcare facility settings.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251592 Date11 Feb 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
QBP
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the SteriHub Disinfecting Device and Protective Cover used for?

    The SteriHub Disinfecting Device and Protective Cover is used to provide active disinfection of needleless connectors and to offer a physical barrier to contamination for up to 7 days if not removed, suitable for use in home or healthcare facility settings.

  • How is the SteriHub Disinfecting Device and Protective Cover supplied?

    The SteriHub Disinfecting Device and Protective Cover is supplied as a device disinfectant cap under product code QBP and regulation number 880.5440, designed for use on needleless connectors in clinical or home environments.

  • Is the SteriHub Disinfecting Device and Protective Cover sterile and single-use?

    The SteriHub Disinfecting Device and Protective Cover is not described as sterile in the provided data, and while it offers protection for up to 7 days if not removed, the data does not specify whether it is intended for single-use or reuse; users should consult labeling for specific instructions on use duration and handling.