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510(k) K220799

K-SHIELD Zen by Sb-Kawasumi Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2022
Date Received
March 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sb-Kawasumi Laboratories, Inc.

  • K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (November 26, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (June 1, 2023)
  • K223810 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (February 24, 2023)

Other clearances for product code JKA

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  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)