Data / Medical devices / United States / Kawasumi Laboratories America, Inc.
Kawasumi Laboratories America, Inc.: FDA-registered device maker in Tampa, FL, United States, 12 510(k) clearances
Kawasumi Laboratories America, Inc. is registered with the FDA (registration 1055927) in Tampa, FL, United States. It lists 8 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 2, 2026.
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- FDA registration number
- 1055927
- FEI number
- 1000113359
- Address
- 10002 Princess Palm Avenue, Suite 324, Tampa, FL, United States, 33619
- Owner or operator
- SB-KAWASUMI LABORATORIES, INC. (8031539)
- Roles
- Complaint file establishment
- First device listed
- January 9, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Non-Coring (Huber) Needle | PTI | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Complaint file establishment | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment | 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 Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, Administration, Intravascular
- All makers of Non-Coring (Huber) Needle
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Set, I.V. Fluid Transfer
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.