HDF Assist Mudule, HDF Infusion Set and Substitution Filter— 510(k) K210575

Substantially Equivalent

Nephros

FDA 510(k) clearance K210575 for HDF Assist Mudule, HDF Infusion Set and Substitution Filter, Substantially Equivalent on 2022-05-13. Applicant: Nephros.

Clearance details

Applicant: Nephros
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2021-02-26
Decision date: 2022-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Orange, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.