← Back to catalogue

Crit-Line IV System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141997

by Fresenius Medical Care

Identifiers

510(k) Number
K141997 FDA 510(k)
FDA Product Code
KOC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Crit-Line IV System is a medical device classified as an accessory to a hemodialysis blood circuit. It is designed to non-invasively monitor a patient's hematocrit, oxygen saturation, and percent change in blood volume in real time during hemodialysis treatment.

This system is authorized for use under FDA 510k clearance. It is intended to assist clinicians in managing dialysis treatments by providing data on blood parameters.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Crit-Line IV Monitor - FMCNA, PDF Crit-Line IV User's Guide - freseniusmedicalcare.com, Fresenius Medical Care Crit-Line IV User's Guide - Manualzz, Crit-line - sigbeta.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Fresenius Medical Care

Sources (1)

  • FDA 510(k) K141997 24 fields · synced Sep 26, 2026