510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K982926Substantially Equivalent

Fresenius Blood Volume Monitor

Fresenius Medical Care Renal Therapies Group, LLC, Wrentham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982926 is the FDA 510(k) clearance record for FRESENIUS BLOOD VOLUME MONITOR, a class II device, cleared for Fresenius Medical Care North America on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show no recalls naming K982926.

Clearance record

Decision date
Received
(379 days to decision)
Product code
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius Medical Care North America 10 Oak Pt., Wrentham MA
510(k) summary
Summary
Third party review
No

Clearances, product code KDI

Trailing 12 months
7 clearances under product code KDI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDI, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20261
November 20260