HDF Assist Mudule, HDF Infusion Set and Substitution Filter
FDA 510(k) K210575 · Nephros
510(k) numberK210575
Submission
- Device name
- HDF Assist Mudule, HDF Infusion Set and Substitution Filter
- Applicant
- Nephros
South Orange, NJ, US - Received
- February 26, 2021
- Decision date
- May 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was HDF Assist Mudule, HDF Infusion Set and Substitution Filter cleared by the FDA?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter (K210575) received a 510(k) decision of Substantially Equivalent on May 13, 2022, 441 days after the submission was received.
What is the product code of K210575?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.