Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination
by Fresenius Medical Care North America
510(k) K991520
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991520 | Date30 Jul 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fresenius Online Clearance Monitor with Access Flow Determination is a medical device classified as a Dialyzer, High Permeability With or Without Sealed Dialysate System. It is designed to measure urea clearance and estimate access flow during hemodialysis treatments, providing real-time monitoring of dialysis efficiency and vascular access performance.
This device is intended for use as a module with the Fresenius 2008H hemodialysis machine, supporting both acute and chronic hemodialysis patients. It is single-use, non-sterile (unless packaged as such), and requires compatibility with MRI environments as specified by the manufacturer. The device holds FDA 510(k) clearance (K991520) and adheres to regulatory standards under 21 CFR 876.5860. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.