Cleared Traditional

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K190485) - FDA 510(k) Clearance

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

K190485 · Kawasumi Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
131d
Days
Class 2
Risk

K190485 is an FDA 510(k) clearance for the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH). Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Tokyo, JP). The FDA issued a Cleared decision on July 8, 2019 after a review of 131 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 Kawasumi Laboratories, Inc. devices

Submission Details

510(k) Number K190485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2019
Decision Date July 08, 2019
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 Consultant

Regulatory Compliance Associates, Inc. (Rca)
Lisa L. Michels

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 236
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K190485.
Female Culture Device
K252899 · Zhejiang Kindly Medical Device Co., Ltd. · Jun 2026
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · Becton, Dickinson and Company · Apr 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
K252378 · Becton, Dickinson and Company · Apr 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · Becton, Dickinson and Company · Apr 2026
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
K252040 · Becton, Dickinson and Company · Mar 2026
Steripath® Flow™ Blood Collection System
K251812 · Magnolia Medical Technologies · Sep 2025