Kawasumi Laboratories Empty Solution Container
FDA 510(k) K061197 · Kawasumi Laboratories, Inc.
510(k) numberK061197
Submission
- Device name
- Kawasumi Laboratories Empty Solution Container
- Applicant
- Kawasumi Laboratories, Inc.
Washington, DC, US - Received
- April 28, 2006
- Decision date
- June 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
Other 510(k)s with product code KPE
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|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 04/02/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | Fresenius Kabi AG | 01/09/2026SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | Epic Medical Pte. , Ltd. | 08/01/2025SE |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection SiteKPE · Special | Epic Medical Pte. , Ltd. | 06/21/2024SE |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110)KPE · Traditional | Epic Medical Pte. , Ltd. | 09/01/2023SE |
| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | Gilero, LLC | 05/06/2021SE |
More from Gilero, LLC
| 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 |
| 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 Empty Solution Container cleared by the FDA?
Kawasumi Laboratories Empty Solution Container (K061197) received a 510(k) decision of Substantially Equivalent on June 30, 2006, 63 days after the submission was received.
What is the product code of K061197?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.