Clave Neutral-Displacement Needlefree Connectors
FDA 510(k) K250616 · Icu Medical, Inc.
510(k) numberK250616
Submission
- Device name
- Clave Neutral-Displacement Needlefree Connectors
- Applicant
- Icu Medical, Inc.
Lake Forest, IL, US - Received
- February 28, 2025
- Decision date
- June 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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| K242115 | Plum Duo Precision IV PumpFRN · Traditional | 04/02/2025SE |
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| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
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Questions and answers
When was Clave Neutral-Displacement Needlefree Connectors cleared by the FDA?
Clave Neutral-Displacement Needlefree Connectors (K250616) received a 510(k) decision of Substantially Equivalent on June 5, 2025, 97 days after the submission was received.
What is the product code of K250616?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.