Pressure Infusor for I.V. Bags/Autoinflation
FDA 510(k) K890268 · Biomedical Dynamics, Inc.
510(k) numberK890268
Submission
- Device name
- Pressure Infusor for I.V. Bags/Autoinflation
- Applicant
- Biomedical Dynamics, Inc.
Minneapolis, MN, US - Received
- January 18, 1989
- Decision date
- May 5, 1989
- 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 |
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| 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 |
|---|---|---|
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | 02/05/1992SE |
| K913751 | Pressure InfuserKZD · Traditional | 01/09/1992SE |
| K911213 | CuffableDXQ · Traditional | 08/07/1991SE |
| K911216 | InfusableKZD · Traditional | 07/22/1991SE |
| K911324 | Irrigation/Aspiration Tubing SetKDH · Traditional | 06/24/1991SE |
| K904376 | Aneroid Blood Pressure GaugeFCY · Traditional | 12/20/1990SE |
| K881799 | Blood Pressure CuffDXQ · Traditional | 10/14/1988SE |
| K861977 | Biomedical Dynamics Disposable Pressure InfusorKZD · Traditional | 07/15/1986SE |
| K850506 | Correct Flo Intravascular Administration SetFPA · Traditional | 04/01/1985SE |
Questions and answers
When was Pressure Infusor for I.V. Bags/Autoinflation cleared by the FDA?
Pressure Infusor for I.V. Bags/Autoinflation (K890268) received a 510(k) decision of Substantially Equivalent on May 5, 1989, 107 days after the submission was received.
What is the product code of K890268?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.