Sb-Kawasumi Laboratories, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing510(k)Nov 26, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)510(k)Mar 26, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 26, 2025
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)510(k)Jun 1, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jun 1, 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)510(k)Feb 24, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Feb 24, 2023
K-SHIELD Zen510(k)Aug 29, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 29, 2022