510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K041683Substantially Equivalent

B. Braun Bicarbonate Dialysate

B.Braun Medical, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041683 is the FDA 510(k) clearance record for B. BRAUN BICARBONATE DIALYSATE, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K041683.

Clearance record

Decision date
Received
(67 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
B.Braun Medical, Inc. 901 Marcon Blvd., Allentown PA
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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPO, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260