Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LDW — 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) |
|---|---|---|---|---|---|
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Alpha-Tec Systems, Inc. | 1988-08-04 | 16 | 0 |
| K842923 | PICRIC ACID 1% W/V | E K Ind., Inc. | 1984-09-11 | 48 | 0 |
| K842922 | PICRIC ACID SATURATED SOLUTION | E K Ind., Inc. | 1984-09-07 | 44 | 0 |
| K831058 | SAF FIXATIVE | American Micro Scan | 1983-06-08 | 68 | 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