Cleared Traditional

Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) - FDA 510(k) Clearance

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

K172957 · Kawasumi Laboratories, Inc. · General Hospital
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Sep 2018
Decision
367d
Days
Class 2
Risk

K172957 is an FDA 510(k) clearance for the Kawasumi Laboratories Blood Drawing Kit (BDK) System. Classified as Set, Transfer (blood/plasma) (product code KSB), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Tokyo, JP). The FDA issued a Cleared decision on September 28, 2018 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 864.9875 - 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. Elevated predicate reliance profile. 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 K172957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date September 28, 2018
Days to Decision 367 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
238d slower than avg
Panel avg: 129d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSB Set, Transfer (blood/plasma)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9875
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.
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.