Infumix Mixing Container
FDA 510(k) K870052 · Biodynamics Corp.
510(k) numberK870052
Submission
- Device name
- Infumix Mixing Container
- Applicant
- Biodynamics Corp.
Houston, TX, US - Received
- January 7, 1987
- Decision date
- February 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K051675 | Biodynamics Bia 500 Biompedance Body Composition AnalyzerMNW · Traditional | 03/16/2006SE |
| K884033 | Biodynamics Model 200 Body Composition AnalyzerDSB · Traditional | 11/17/1988SE |
| K881631 | Biodynamics Autotransfusion ReservoirCAC · Traditional | 09/09/1988SE |
| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | 07/28/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | 03/16/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | 03/09/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | 10/23/1987SE |
| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
| K822715 | Platelet CentrifugeJQC · Traditional | 09/30/1982SE |
| K822422 | Basic CentrifugeJQC · Traditional | 09/02/1982SE |
Questions and answers
When was Infumix Mixing Container cleared by the FDA?
Infumix Mixing Container (K870052) received a 510(k) decision of Substantially Equivalent on February 27, 1987, 51 days after the submission was received.
What is the product code of K870052?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.