Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shandon, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
61 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893663 | INSTANT EOSIN-AQUEOUS | Shandon, Inc. | 1989-06-13 | 29 | 0 |
| K890984 | LINISTAIN SLS | Shandon, Inc. | 1989-04-04 | 36 | 0 |
| K880240 | INSTANT EOSIN-ALCOHOLIC | Shandon, Inc. | 1988-03-03 | 43 | 0 |
| K873107 | INSTANT HEMATOXYLIN | Shandon, Inc. | 1987-08-21 | 14 | 0 |
| K780261 | COVERSLIPPER | Shandon, Inc. | 1978-04-18 | 61 | 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