Company ยท US
Kawasumi Laboratories Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2019. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 10 |
| FMI | Needle, Hypodermic, Single Lumen | 5 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FRN | Pump, Infusion | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| KPE | Container, I.V. | 1 |
| KSB | Set, Transfer (Blood/Plasma) | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2019 | K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Kawasumi Laboratories, Inc., JP | JKA |
| May 2, 2019 | K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) Kawasumi Laboratories, Inc., JP | FPA |
| Sep 28, 2018 | K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System Kawasumi Laboratories, Inc., JP | KSB |
| Mar 7, 2013 | K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) Kawasumi Laboratories, Inc. | FPA |
| Nov 18, 2010 | K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING Kawasumi Laboratories, Inc. | FPA |
| Nov 3, 2010 | K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FMI |
| Jan 25, 2008 | K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FMI |
| Jun 30, 2006 | K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER Kawasumi Laboratories, Inc. | KPE |
| Jun 6, 2006 | K060580 | K-SHIELD PORT ACCESS INFUSION SET Kawasumi Laboratories, Inc. | FPA |
| Feb 26, 2003 | K023917 | WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FPA |
| Sep 12, 2002 | K022110 | KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. Kawasumi Laboratories, Inc. | LJT |
| Mar 8, 2000 | K994323 | KAWASUMI LABORATORIES PHILEBOTOMY SET Kawasumi Laboratories Co., Ltd. | LHI |
| Feb 12, 1998 | K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) Kawasumi Laboratories Co., Ltd. | LJT |
| Mar 14, 1997 | K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE Kawasumi Laboratories Co., Ltd. | LJT |
| Feb 10, 1994 | K935514 | VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER Kawasumi Laboratories Co., Ltd., JP | FMI |
| Feb 3, 1994 | K935506 | MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION Kawasumi Laboratories Co., Ltd., JP | FMI |
| Feb 3, 1994 | K935505 | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER Kawasumi Laboratories Co., Ltd., JP | FMI |
| Dec 14, 1993 | K930012 | KAWASUMI LABORATORIES K-CUFF Kawasumi Laboratories Co., Ltd., JP | KZD |
| Sep 10, 1993 | K921901 | PORT ACCESS INFUSION SET Kawasumi Laboratories Co., Ltd., JP | FRN |
| Jul 28, 1993 | K921902 | PORT ACCESS NEEDLE Kawasumi Laboratories Co., Ltd., JP | LJT |
| Jul 13, 1993 | K923323 | INTERMITTENT INJECTION SITE Kawasumi Laboratories Co., Ltd., JP | FOZ |
| Sep 12, 1990 | K896896 | KAWASUMI SMALL VEIN INFUSION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896895 | KAWASUMI I.V. ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896894 | KAWASUMI BLOOD ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896893 | KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE Kawasumi Laboratories Co., Ltd. | FPA |
| Sep 12, 1990 | K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET Kawasumi Laboratories Co., Ltd. | FPA |
| Jan 31, 1989 | K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS Kawasumi Laboratories Co., Ltd., JP | FJI |
| Oct 9, 1987 | K873421 | KAWASUMI A.V. FISTULA SET Kawasumi Laboratories Co., Ltd. | FKQ |
| Oct 5, 1987 | K873516 | KAWASUMI BLOOD TUBING LINE Kawasumi Laboratories Co., Ltd. | FJK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||