Cleared Traditional

K191832 - Kurin Blood Culture Collection Set with...

K191832 is an FDA 510(k) clearance for Kurin Blood Culture Collection Set with..., manufactured by Kurin, Inc.. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K191832 · Kurin, Inc. · General Hospital
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Feb 2020
Decision
210d
Days
Class 2
Risk

K191832 is an FDA 510(k) clearance for the Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Ne.... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Kurin, Inc. (San Diego, US). The FDA issued a Cleared decision on February 4, 2020 after a review of 210 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 Kurin, Inc. devices

FDA 510(k) Submission Details - K191832

510(k) Number K191832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date February 04, 2020
Days to Decision 210 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
81d slower than avg
Panel avg: 129d · This submission: 210d
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 Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 125
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K191832.
Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
K200027 · Jiangsu Caina Medical Co.,Ltd · Sep 2020
Bevel Up Holder
K193074 · Nsp Tech Pte, Ltd. · Apr 2020
Steripath Gen2 Blood Collection System
K192247 · Magnolia Medical Technologies, Inc. · Feb 2020
PIVO(TM)
K193569 · Velano Vascular · Jan 2020
Blood Transfer Accessory (BTA)
K181743 · Nsp Tech Pte, Ltd. · Jul 2019
Blood Collection Accessory (BUCA)
K181754 · Nsp Tech Pte, Ltd. · Jul 2019