510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030497Substantially Equivalent

Fresenius Naturalyte Granuflo Dry Acid Concentrate 10Xx Series, 24Xx Series, 30Xx Series

Fresenius Medical Care, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030497 is the FDA 510(k) clearance record for FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES, a class II device, cleared for Fresenius Medical Care on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 7 510(k) clearances for Fresenius Medical Care, from to . As of , FDA records show 14 recalls naming K030497.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius Medical Care 95 Hayden Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPO

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