SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
FDA 510(k) K201936 · Gilero, LLC
510(k) numberK201936
Submission
- Device name
- SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
- Applicant
- Gilero, LLC
Morrisville, NC, US - Received
- July 13, 2020
- Decision date
- May 6, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
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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 |
| K193528 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 07/22/2020SE |
More from Haemotronic S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K230718 | UTC 3mL Medication CartridgeMRZ · Traditional | 06/15/2023SE |
Questions and answers
When was SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL cleared by the FDA?
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936) received a 510(k) decision of Substantially Equivalent on May 6, 2021, 297 days after the submission was received.
What is the product code of K201936?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.