Cleared Traditional

K-SHIELD Zen

K220799 · Sb-Kawasumi Laboratories, Inc. · General Hospital
Aug 2022
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K220799 is an FDA 510(k) clearance for the K-SHIELD Zen, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sb-Kawasumi Laboratories, Inc. (Kanagawa, JP). The FDA issued a Cleared decision on August 29, 2022, 164 days after receiving the submission on March 18, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K220799 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2022
Decision Date August 29, 2022
Days to Decision 164 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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