510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001059Substantially Equivalent

Normocarb Sterile Bicarbonate Renal Dialysis

Novex Pharma, Richmond Hill, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001059 is the FDA 510(k) clearance record for NORMOCARB STERILE BICARBONATE RENAL DIALYSIS, a class II device, cleared for Novex Pharma on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list one 510(k) clearance for Novex Pharma. As of , FDA records show no recalls naming K001059.

Clearance record

Decision date
Received
(88 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
Novex Pharma 380 Elgin Mills Rd. E., Richmond Hill, Ontario, CA
510(k) summary
Summary
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