Kawasumi Laboratories Co., Ltd.
Washington, DC, US
Kawasumi Laboratories Co., Ltd. appears in FDA device records in Washington, DC. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Kawasumi Laboratories Co., Ltd. between 1987 and 2019. The busiest year on record is 1990, with 5. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 5 |
| 1993 | 4 |
| 1994 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2010 | 2 |
| 2013 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | JKA | Substantially Equivalent | |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | FPA | Substantially Equivalent | |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | KSB | Substantially Equivalent | |
| K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) | FPA | Substantially Equivalent | |
| K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING | FPA | Substantially Equivalent | |
| K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR | FMI | Substantially Equivalent | |
| K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR | FMI | Substantially Equivalent | |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | KPE | Substantially Equivalent | |
| K060580 | K-SHIELD PORT ACCESS INFUSION SET | FPA | Substantially Equivalent | |
| K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR | FPA | Substantially Equivalent | |
| K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. | LJT | Substantially Equivalent | |
| K994323 | KAWASUMI LABORATORIES PHILEBOTOMY SET | LHI | Substantially Equivalent | |
| K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) | LJT | Substantially Equivalent | |
| K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE | LJT | Substantially Equivalent | |
| K935514 | VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER | FMI | Substantially Equivalent | |
| K935506 | MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION | FMI | Substantially Equivalent | |
| K935505 | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER | FMI | Substantially Equivalent | |
| K930012 | KAWASUMI LABORATORIES K-CUFF | KZD | Substantially Equivalent | |
| K921901 | PORT ACCESS INFUSION SET | FRN | Substantially Equivalent | |
| K921902 | PORT ACCESS NEEDLE | LJT | Substantially Equivalent | |
| K923323 | INTERMITTENT INJECTION SITE | FOZ | Substantially Equivalent | |
| K896896 | KAWASUMI SMALL VEIN INFUSION SET | FPA | Substantially Equivalent | |
| K896895 | KAWASUMI I.V. ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K896894 | KAWASUMI BLOOD ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K896893 | KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE | FPA | Substantially Equivalent | |
| K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS | FJI | Substantially Equivalent | |
| K873421 | KAWASUMI A.V. FISTULA SET | FKQ | Substantially Equivalent | |
| K873516 | KAWASUMI BLOOD TUBING LINE | FJK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- KPEContainer, I.V.
- FJIDialyzer, Capillary, Hollow Fiber
- KZDInfusor, Pressure, For I.V. Bags
- FMINeedle, Hypodermic, Single Lumen
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- KSBSet, Transfer (Blood/Plasma)
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain