Kawasumi Laboratories K-Cuff
FDA 510(k) K930012 · Kawasumi Laboratories Co., Ltd.
510(k) numberK930012
Submission
- Device name
- Kawasumi Laboratories K-Cuff
- Applicant
- Kawasumi Laboratories Co., Ltd.
Tokyo, JP - Received
- January 4, 1993
- Decision date
- December 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K953290 | Olympus Automatic Surgical Irrigation PumpKZD · Traditional | Olympus America, Inc. | 10/07/1995SE |
| K951988 | PressurizerKZD · Traditional | Promedic, Inc. | 06/14/1995SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | Circulatory Technology, Inc. | 08/25/1994SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
| K904484 | Baxter Single Patient Use Pressure InfusorKZD · Traditional | Tecnadyne Scientific, Inc. | 10/26/1990SE |
More from Tecnadyne Scientific, 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 |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | 09/28/2018SE |
| 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 |
Questions and answers
When was Kawasumi Laboratories K-Cuff cleared by the FDA?
Kawasumi Laboratories K-Cuff (K930012) received a 510(k) decision of Substantially Equivalent on December 14, 1993, 344 days after the submission was received.
What is the product code of K930012?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.