NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER— 510(k) K112314

Substantially Equivalent

Nephros, Inc.

FDA 510(k) clearance K112314 for NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER, Substantially Equivalent on 2012-04-27. Applicant: Nephros, Inc..

Clearance details

Applicant: Nephros, Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2011-08-11
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: River Edge, 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.