Empty EVA Bag
FDA 510(k) K193528 · Haemotronic S.P.A.
510(k) numberK193528
Submission
- Device name
- Empty EVA Bag
- Applicant
- Haemotronic S.P.A.
Mirandola, IT - Received
- December 19, 2019
- Decision date
- July 22, 2020
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K210749 | Empty EVA BagKPE · Traditional | 08/19/2021SE |
Questions and answers
When was Empty EVA Bag cleared by the FDA?
Empty EVA Bag (K193528) received a 510(k) decision of Substantially Equivalent on July 22, 2020, 216 days after the submission was received.
What is the product code of K193528?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.