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510(k) K172957

Kawasumi Laboratories Blood Drawing Kit (BDK) System by Kawasumi Laboratories, Inc. — Product Code KSB

K172957 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "Kawasumi Laboratories Blood Drawing Kit (BDK) System". The FDA issued a decision of Substantially Equivalent on September 28, 2018. The device falls under product code KSB (Set, Transfer (Blood/Plasma)), a Class II device regulated under 21 CFR 864.9875. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2018
Date Received
September 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Transfer (Blood/Plasma)
Device Class
Class II
Regulation Number
864.9875
Review Panel
HE
Submission Type

Other clearances by Kawasumi Laboratories, Inc.

  • K190485 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (July 8, 2019)
  • K190233 — K-Shield Advantage Port Access Infusion Set (PAIS) (May 2, 2019)
  • 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 KSB

  • K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT (May 19, 2000)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K802940 — SUPER-SPIKE TRANSFER SET (January 15, 1981)
  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)

FDA data resources