510(k) Report

FDA applicant

Novex Pharma

Richmond Hill, Ontario, CA1 decision2000–20000 recalls

FDA records 1 decision for Novex Pharma (Richmond Hill, Ontario, CA) in 2000: 1 510(k) clearance. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Novex Pharma’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novex Pharma since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Novex Pharma by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001059Normocarb Sterile Bicarbonate Renal DialysisNovex Pharma · 20002cite it

What has FDA decided for it lately?

  • K001059Normocarb Sterile Bicarbonate Renal DialysisNovex Pharma · 2000

The one decision as Novex Pharma →