Home / 510(k) Clearances / K190485

510(k) K190485

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) by Kawasumi Laboratories, Inc. — Product Code JKA

K190485 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)". The FDA issued a decision of Substantially Equivalent on July 8, 2019. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2019
Date Received
February 27, 2019
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 Kawasumi Laboratories, Inc.

  • K190233 — K-Shield Advantage Port Access Infusion Set (PAIS) (May 2, 2019)
  • K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) System (September 28, 2018)
  • K123344 — K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) (March 7, 2013)
  • K100720 — K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING (November 18, 2010)
  • K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR (November 3, 2010)
  • K073257 — KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR (January 25, 2008)
  • K061197 — KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER (June 30, 2006)
  • K060580 — K-SHIELD PORT ACCESS INFUSION SET (June 6, 2006)
  • K023917 — WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR (February 26, 2003)
  • K022110 — KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSI (September 12, 2002)

Other clearances for product code JKA

  • K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device (June 2, 2026)
  • K260128 — BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (April 15, 2026)
  • K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Bloo (April 10, 2026)
  • K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillar (April 10, 2026)
  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • 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)

FDA data resources