Cleared Traditional

K200027 - Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

K200027 is an FDA 510(k) clearance for Blood Collection Needle with/without Holder, manufactured by Jiangsu Caina Medical Co.,Ltd. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K200027 · Jiangsu Caina Medical Co.,Ltd · General Hospital
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Sep 2020
Decision
247d
Days
Class 2
Risk

K200027 is an FDA 510(k) clearance for the Blood Collection Needle with/without Holder, Safety Blood Collection Needle w.... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on September 9, 2020 after a review of 247 days - an extended review cycle.

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 Caina Medical Co.,Ltd devices

FDA 510(k) Submission Details - K200027

510(k) Number K200027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2020
Decision Date September 09, 2020
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 164
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K200027.
EasyPoint Blood Collection Plus
K202325 · Retractable Technologies, Inc. · Apr 2021
Safety Blood Collection Sets for Single Use
K202188 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Feb 2021
BD Preset Syringe & BD A-Line Syringe
K202446 · Becton, Dickinson and Company · Sep 2020
Bevel Up Holder
K193074 · Nsp Tech Pte, Ltd. · Apr 2020
Steripath Gen2 Blood Collection System
K192247 · Magnolia Medical Technologies, Inc. · Feb 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
K191832 · Kurin, Inc. · Feb 2020