Kawasumi Laboratories Blood Drawing Kit (BDK) System
FDA 510(k) K172957 · Kawasumi Laboratories, Inc.
510(k) numberK172957
Submission
- Device name
- Kawasumi Laboratories Blood Drawing Kit (BDK) System
- Applicant
- Kawasumi Laboratories, Inc.
Tokyo, JP - Received
- September 26, 2017
- Decision date
- September 28, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KSB – Set, Transfer (Blood/Plasma)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9875
- Specialty
- Hematology
Other 510(k)s with product code KSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001043 | Kawasumi Laboratory Blood Drawing KitKSB · Traditional | Kawasumi Laboratories America, Inc. | 05/19/2000SE |
| K820447 | Alpha Plasma Transfer SetKSB · Traditional | Alpha Therapeutic Corp. | 04/14/1982SE |
| K802940 | Super-Spike Transfer SetKSB · Traditional | Geneva Laboratories, Inc. | 01/15/1981SE |
| K791131 | Flu Ven TR-1KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
| K791130 | Flu-Ven TK-2KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
More from Venospital, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA · Traditional | 07/08/2019SE |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS)FPA · Special | 05/02/2019SE |
| K123344 | K-Shield Advantage Port Access Infusion Set (Pais)FPA · Traditional | 03/07/2013SE |
| K100720 | K-Shield Port Access Infusion Set with High Pressure TubingFPA · Traditional | 11/18/2010SE |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorFMI · Special | 11/03/2010SE |
| K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorFMI · Traditional | 01/25/2008SE |
| K061197 | Kawasumi Laboratories Empty Solution ContainerKPE · Traditional | 06/30/2006SE |
| K060580 | K-Shield Port Access Infusion SetFPA · Traditional | 06/06/2006SE |
| K023917 | Winged Needle Sets with an Antineedle Stick ProtectorFPA · Traditional | 02/26/2003SE |
| K022110 | Kawasumi Laboratories Antineedle Stick Protector for Use with Port Access Infusion Sets.LJT · Traditional | 09/12/2002SE |
Questions and answers
When was Kawasumi Laboratories Blood Drawing Kit (BDK) System cleared by the FDA?
Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) received a 510(k) decision of Substantially Equivalent on September 28, 2018, 367 days after the submission was received.
What is the product code of K172957?
The FDA product code is KSB – Set, Transfer (Blood/Plasma), a Class II (moderate risk) device regulated under 21 CFR 864.9875.