Cleared Traditional

Vial Adapter (K260301) - FDA 510(k) Clearance

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

K260301 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · General Hospital
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Jun 2026
Decision
126d
Days
Class 2
Risk

K260301 is an FDA 510(k) clearance for the Vial Adapter. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 5, 2026 after a review of 126 days - within the typical 510(k) review window.

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 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K260301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date June 05, 2026
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
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 205
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K260301.
Medline Bag Decanter
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HyHub™ and HyHub™ Duo Vial Access Devices
K243404 · Takeda Pharmaceuticals · Jul 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
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Rio™ Drug Reconstitution Transfer Device
K243985 · Icu Medical, Inc. · Jan 2025