Rockwell Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Rockwell Medical Technologies, Inc.” (first 1999, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time under this name: 147 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 5 | 5 |
Review panels
Most recent Rockwell Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | KPO | 2006-11-17 | 93 |
| K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE | KPO | 2003-02-28 | 88 |
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON | KPO | 2003-01-03 | 157 |
| K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | KPO | 2002-12-23 | 147 |
| K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE | KPO | 1999-08-05 | 294 |
Recalls
7 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2008-09-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Rockwell Medical Technologies, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01322347: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) (Completed, started 2011-04)
- NCT01320202: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (Completed, started 2011-03)
- NCT00548249: Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis (Completed, started 2007-08)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Rockwell Medical (1 510(k)s)
- Rockwell Medical Supply (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rockwell Medical Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Rockwell Medical Technologies, Inc.” (first 1999, latest 2006), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rockwell Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rockwell Medical Technologies, Inc. is 147 days.
Which FDA product codes appear under Rockwell Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 5).
Next steps
- See all 5 Rockwell Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPO, Rockwell Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.