FDA applicant

Rockwell Medical Supply

Wixom, MI1 decision1996–19963 recalls

FDA records 1 decision for Rockwell Medical Supply (Wixom, MI) in 1996: 1 510(k) clearance. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). 3 recalls are 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 Rockwell Medical Supply’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rockwell Medical Supply since 2007.

Recalls per year

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Rockwell Medical Supply’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 “Rockwell”

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

Rockwell Medical Technologies, Inc. 5 Rockwell Medical 1

Rockwell Medical Supply

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Rockwell”