510(k) Report

FDA applicant

Granite Chemical Co., Inc.

Mount Airy, NC3 decisions1990–19900 recalls

FDA records 3 decisions for Granite Chemical Co., Inc. (Mount Airy, NC) in 1990: 3 510(k) clearances. 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 Granite Chemical Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Granite Chemical Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Granite Chemical Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Granite”

FDA records each applicant name separately; these may or may not be the same firm.