Empty Mixing Container
FDA 510(k) K932641 · Douglas Medical Products Corp.
510(k) numberK932641
Submission
- Device name
- Empty Mixing Container
- Applicant
- Douglas Medical Products Corp.
Mundelein, IL, US - Received
- June 2, 1993
- Decision date
- November 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
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| K941628 | 40 Micron Blood Transfusion FilterFPB · Traditional | 02/16/1995SE |
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| K930854 | Solution Set with .2 Micron FilterFPA · Traditional | 01/14/1994SE |
| K932637 | Subcutaneous Infusion SetFPA · Traditional | 01/07/1994SE |
| K931659 | 3 Lead ConnectorFPA · Traditional | 01/07/1994SE |
| K931658 | In-Line Burette SetFPA · Traditional | 12/21/1993SE |
Questions and answers
When was Empty Mixing Container cleared by the FDA?
Empty Mixing Container (K932641) received a 510(k) decision of Substantially Equivalent on November 10, 1993, 161 days after the submission was received.
What is the product code of K932641?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.