Sb-Kawasumi Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K220799 | K-SHIELD Zen | August 29, 2022 |