Cleared Traditional

K190485 - Kawasumi Multiple Sample Adapter with P...

K190485 is the FDA 510(k) clearance for Kawasumi Multiple Sample Adapter with P... by Kawasumi Laboratories, Inc.. It is a Class 2 General Hospital device (product code JKA) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K190485 · Kawasumi Laboratories, Inc. · General Hospital
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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 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K190485.
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