Cleared Special

K223810 - Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223810 · Sb-Kawasumi Laboratories, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2023
Decision
66d
Days
Class 2
Risk

K223810 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 Sb-Kawasumi Laboratories, Inc. (Kawasaki-Shi, JP). The FDA issued a Cleared decision on February 24, 2023 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sb-Kawasumi Laboratories, Inc. devices

Submission Details

510(k) Number K223810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2022
Decision Date February 24, 2023
Days to Decision 66 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 128d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 235
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K223810.
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