Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Royco Instruments — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800104 | ROYCO MODEL 951 CELL MIXER | Royco Instruments | 1980-02-06 | 21 | 0 |
| K791867 | ROYCO MODEL 921 CELL COUNTER | Royco Instruments | 1979-11-05 | 45 | 0 |
| K791644 | ROYCO MODEL 371 SUPER DILUTOR | Royco Instruments | 1979-09-19 | 27 | 0 |
| K790442 | ISOTONIC DILUENT | Royco Instruments | 1979-04-04 | 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