Cleared Traditional

K243404 - HyHub™ and HyHub™ Duo Vial Access Devices (FDA 510(k) Clearance)

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

K243404 · Takeda Pharmaceuticals · General Hospital
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Jul 2025
Decision
259d
Days
Class 2
Risk

K243404 is an FDA 510(k) clearance for the HyHub™ and HyHub™ Duo Vial Access Devices. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Takeda Pharmaceuticals (Cambridge, US). The FDA issued a Cleared decision on July 18, 2025 after a review of 259 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 Takeda Pharmaceuticals devices

Submission Details

510(k) Number K243404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2024
Decision Date July 18, 2025
Days to Decision 259 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
131d slower than avg
Panel avg: 128d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 Peers - LHI Set, I.v. Fluid Transfer

All 204
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K243404.
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K240761 · Yukon Medical, LLC · Mar 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · Icu Medical, Inc. · Jan 2025
SmartSiteTM Vented Vial Access Device
K243486 · Yukon Medical, LLC · Dec 2024