510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K131611Substantially Equivalent

Fresenius Dry Acid Dissolution Units

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

K131611 is the FDA 510(k) clearance record for FRESENIUS DRY ACID DISSOLUTION UNITS, a class II device, cleared for Fresenius Medical Care North America on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show 2 recalls naming K131611.

Clearance record

Decision date
Received
(87 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 North America 920 Winter St., Waltham MA
510(k) summary
Statement
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