Cleared Traditional

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 (K232881) - 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
34d faster than avg
Panel avg: 129d · 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.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 100
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K232881.
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · Becton, Dickinson and Company · Feb 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · Lifeoutcomes, LLC · Jan 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · Becton, Dickinson and Company · Jan 2024
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · Becton, Dickinson and Company · Dec 2023
Monarch Blood Collection Set
K232308 · The Monarch Company · Dec 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
K230391 · Becton, Dickinson and Company · Dec 2023