Cleared Traditional

K243404 - HyHub and HyHub Duo Vial Access Devices

K243404 is an FDA 510(k) clearance for HyHub and HyHub Duo Vial Access Devices, manufactured by Takeda Pharmaceuticals. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

FDA 510(k) Submission Details - K243404

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
130d slower than avg
Panel avg: 129d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K243404.
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