ClaveQS Bag
FDA 510(k) K251980 · Icu Medical, Inc.
510(k) numberK251980
Submission
- Device name
- ClaveQS Bag
- Applicant
- Icu Medical, Inc.
San Clemente, CA, US - Received
- June 27, 2025
- Decision date
- March 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
| K193528 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 07/22/2020SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | 06/05/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
| K223607 | Plum Duo Infusion SystemFRN · Traditional | 08/24/2023SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | 08/24/2023SE |
Questions and answers
When was ClaveQS Bag cleared by the FDA?
ClaveQS Bag (K251980) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 266 days after the submission was received.
What is the product code of K251980?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.