Cleared Traditional

K251592 - SteriHub™ Disinfecting Device and Protective Cover (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251592 · 1World Vista Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
264d
Days
Class 2
Risk

K251592 is an FDA 510(k) clearance for the SteriHub™ Disinfecting Device and Protective Cover. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by 1World Vista Medical (Rio Verde, US). The FDA issued a Cleared decision on February 11, 2026 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all 1World Vista Medical devices

Submission Details

510(k) Number K251592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2025
Decision Date February 11, 2026
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 128d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBP Cap, Device Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Honkanen Consultanting, Inc.
Laurie Lewandowski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.