Rio Drug Reconstitution Transfer Device
FDA 510(k) K243985 · Icu Medical, Inc.
510(k) numberK243985
Submission
- Device name
- Rio Drug Reconstitution Transfer Device
- Applicant
- Icu Medical, Inc.
San Clemente, CA, US - Received
- December 23, 2024
- Decision date
- January 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Rio Drug Reconstitution Transfer Device cleared by the FDA?
Rio Drug Reconstitution Transfer Device (K243985) received a 510(k) decision of Substantially Equivalent on January 22, 2025, 30 days after the submission was received.
What is the product code of K243985?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.