Churchill Medical Dual Chamber Empty Container
FDA 510(k) K041038 · Churchill Medical Systems, Inc.
510(k) numberK041038
Submission
- Device name
- Churchill Medical Dual Chamber Empty Container
- Applicant
- Churchill Medical Systems, Inc.
Dover, NH, US - Received
- April 22, 2004
- Decision date
- December 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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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| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
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| 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 |
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| K013950 | Vented Vial Access DeviceFPA · Traditional | 01/10/2002SE |
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| K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer LockFPA · Traditional | 06/12/2001SE |
| K896333 | CMS IV FiltersFPB · Traditional | 01/11/1990SE |
| K894954 | .22 & 1.2 Micron IV FiltersFPB · Traditional | 11/13/1989SE |
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Questions and answers
When was Churchill Medical Dual Chamber Empty Container cleared by the FDA?
Churchill Medical Dual Chamber Empty Container (K041038) received a 510(k) decision of Substantially Equivalent on December 21, 2004, 243 days after the submission was received.
What is the product code of K041038?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.