510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K133299Substantially Equivalent

Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand Assembly

Fresenius Medical Care, North America - Renal Ther, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133299 is the FDA 510(k) clearance record for ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY, a class II device, cleared for Fresenius Medical Care, North America - Renal Ther on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list one 510(k) clearance for Fresenius Medical Care, North America - Renal Ther. As of , FDA records show no recalls naming K133299.

Clearance record

Decision date
Received
(255 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 - Renal Ther 920 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDI

Trailing 12 months
6 clearances under product code KDI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260