Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k) K251636 · Baxter Healthcare Corporation
510(k) numberK251636
Submission
- Device name
- Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- Applicant
- Baxter Healthcare Corporation
Deerfield Lake, IL, US - Received
- May 29, 2025
- Decision date
- July 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) cleared by the FDA?
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) received a 510(k) decision of Substantially Equivalent on July 28, 2025, 60 days after the submission was received.
What is the product code of K251636?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.