FDA applicant

Rockwell Medical Technologies, Inc.

Wixom, MI5 decisions1999–20062 recalls

FDA records 5 decisions for Rockwell Medical Technologies, Inc. (Wixom, MI) from 1999 to 2006: 5 510(k) clearances. All are in product code KPO (Dialysate Concentrate For Hemodialysis (Liquid…). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 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 Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rockwell Medical Technologies, Inc. since 2007.

Recalls per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Rockwell Medical Technologies, 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 “Rockwell”

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

Rockwell Medical Supply 1 Rockwell Medical 1

Rockwell Medical Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

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”