Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Rockwell Medical Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | Rockwell Medical Technologies, Inc. | 2006-11-17 | 93 | 0 |
| K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CO | Rockwell Medical Technologies, Inc. | 2003-02-28 | 88 | 0 |
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 1 | Rockwell Medical Technologies, Inc. | 2003-01-03 | 157 | 2 |
| K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | Rockwell Medical Technologies, Inc. | 2002-12-23 | 147 | 0 |
| K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCEN | Rockwell Medical Technologies, Inc. | 1999-08-05 | 294 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda