Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CEI · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | 2005-02-15 | 81 | 0 |
| K914039 | SODIUM REAGENT SET | Sterling Diagnostics, Inc. | 1991-10-31 | 51 | 0 |
| K902572 | SODIUM REAGENT SET | Tech Intl. Co. | 1990-07-10 | 29 | 0 |
| K832552 | SODIUM TEST KIT | Mallinckrodt Critical Care | 1983-09-20 | 50 | 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