Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Giles Scientific, Inc. — 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) |
|---|---|---|---|---|---|
| K944319 | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM | Giles Scientific, Inc. | 1994-12-15 | 104 | 0 |
| K932122 | BIOMIC VIDEO PLATE READER | Giles Scientific, Inc. | 1994-03-01 | 302 | 0 |
| K854521 | BIOGRAM | Giles Scientific, Inc. | 1985-12-23 | 41 | 0 |
| K843725 | BIOGRAM | Giles Scientific, Inc. | 1985-05-21 | 239 | 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