Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KDX — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
34 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872625 | DECALCIFYING SOLUTION | Stephens Scientific | 1987-08-06 | 31 | 0 |
| K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | Fisher Scientific Co., LLC | 1985-03-20 | 29 | 0 |
| K842726 | DECALCIFIER SOLUTION | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K841488 | DECALCIFIER I | Surgipath Medical Industries, Inc. | 1984-05-02 | 22 | 0 |
| K822036 | VOLU-SOL DECALCIFER | Volu Sol Medical Industries | 1982-08-03 | 22 | 0 |
| K821443 | FORMICAL | Lerner Laboratories, Inc. | 1982-06-02 | 19 | 0 |
| K811801 | CAL-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 | 34 | 0 |
| K810836 | DECALCIFIER II | Surgipath | 1981-04-23 | 28 | 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