Cleared Traditional

K232881 - Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (FDA 510(k) Clearance)

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

K232881 · Jiangsu Kangbao Medical Equipment Co., Ltd. · General Hospital

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Dec 2023

Decision

95d

Days

Class 2

Risk

K232881 is an FDA 510(k) clearance for the Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood .... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on December 22, 2023 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - 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 Jiangsu Kangbao Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number	K232881 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 2023
Decision Date	December 22, 2023
Days to Decision	95 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

33d faster than avg

Panel avg: 128d · This submission: 95d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1675

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.