Sb-Kawasumi Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing, SB Knife Jr2 (MD-47702 and MD-47702L), K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sb-Kawasumi Laboratories, Inc. General Hospital ✕
4 devices
Cleared
Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
General Hospital
120d
Cleared
Jun 01, 2023
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
General Hospital
106d
Cleared
Feb 24, 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
General Hospital
66d
Cleared
Aug 29, 2022
K-SHIELD Zen
General Hospital
164d