Data / Medical devices / Thailand / Kawasumi Laboratories (thailand) Co., Ltd.
Kawasumi Laboratories (thailand) Co., Ltd.: FDA-registered device maker in CHOK CHAI Nakhon Ratchasima, Thailand, 12 510(k) clearances
Kawasumi Laboratories (thailand) Co., Ltd. is registered with the FDA (registration 9615908) in CHOK CHAI Nakhon Ratchasima, Thailand. It lists 10 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 26, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9615908
- FEI number
- 3003282181
- Address
- 48 Mu 8, Ratchasima-Chok Chai RD, Tambon Tha Ang, Amphoe, CHOK CHAI Nakhon Ratchasima, Thailand, 30190
- Owner or operator
- SB-KAWASUMI LABORATORIES, INC. (8031539)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 9, 2008
- Registered through
- 2026
- Brand names listed
- Haemonetics Cell Saver Elite System, Haemonetics Cell Saver System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Fistula | FIE | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Coring (Huber) Needle | PTI | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 26, 2025 | K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | PTI | Substantially Equivalent | Sb-Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| June 1, 2023 | K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | JKA | Substantially Equivalent | Sb-Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | JKA | Substantially Equivalent | Sb-Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| July 8, 2019 | K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | JKA | Substantially Equivalent | Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| May 2, 2019 | K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | FPA | Substantially Equivalent | Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| September 28, 2018 | K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | KSB | Substantially Equivalent | Kawasumi Laboratories, Inc. | accessdata.fda.gov |
| October 21, 2010 | K102890 | K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) | FPA | Substantially Equivalent | Kawasumi Laboratories America, Inc. | accessdata.fda.gov |
| April 15, 2003 | K030385 | IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR | FPA | Substantially Equivalent | Kawasumi Laboratories America, Inc. | accessdata.fda.gov |
| July 21, 2000 | K001426 | KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER | FPA | Substantially Equivalent | Kawasumi Laboratories America, Inc. | accessdata.fda.gov |
| July 21, 2000 | K001424 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD | FPA | Substantially Equivalent | Kawasumi Laboratories America, Inc. | accessdata.fda.gov |
| September 10, 1993 | K921901 | PORT ACCESS INFUSION SET | FRN | Substantially Equivalent | Kawasumi Laboratories Co., Ltd. | accessdata.fda.gov |
| July 13, 1993 | K923323 | INTERMITTENT INJECTION SITE | FOZ | Substantially Equivalent | Kawasumi Laboratories Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Needle, Fistula
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Pump, Infusion
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Non-Coring (Huber) Needle
Updated November 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.