Gri-Flex, Models 1000ML, 500ML, 250ML, 100ML
FDA 510(k) K031419 · Laboratorios Grifols, S.A.
510(k) numberK031419
Submission
- Device name
- Gri-Flex, Models 1000ML, 500ML, 250ML, 100ML
- Applicant
- Laboratorios Grifols, S.A.
Parets Del Valles, Barcelona, ES - Received
- May 5, 2003
- Decision date
- November 24, 2003
- 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 |
| 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 |
|---|---|---|
| K162216 | Gri-Fill Peristaltic SetLHI · Abbreviated | 10/19/2017SE |
| K102590 | Fleboset DoubleLHI · Abbreviated | 01/13/2011SE |
| K093182 | Set Gri-Fill 3.0LHI · Abbreviated | 01/27/2010SE |
| K082752 | QuickpinLHI · Traditional | 09/29/2008SE |
| K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLHI · Traditional | 02/25/2005SE |
| K040456 | Fleboset MultipleLHI · Traditional | 03/09/2004SE |
| K033916 | Gri-Bag, Gri-Bag ApKPE · Traditional | 12/30/2003SE |
| K033682 | Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection TubeLHI · Traditional | 12/17/2003SE |
Questions and answers
When was Gri-Flex, Models 1000ML, 500ML, 250ML, 100ML cleared by the FDA?
Gri-Flex, Models 1000ML, 500ML, 250ML, 100ML (K031419) received a 510(k) decision of Substantially Equivalent on November 24, 2003, 203 days after the submission was received.
What is the product code of K031419?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.