Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gds Diagnostics — 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) |
|---|---|---|---|---|---|
| K931257 | ACETASITE | Gds Diagnostics | 1993-07-08 | 118 | 0 |
| K910881 | CONTROL AND LINEARITY | Gds Diagnostics | 1991-09-13 | 196 | 0 |
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | Gds Diagnostics | 1991-03-04 | 53 | 0 |
| K891761 | GDS ENZYMATIC THEOPHYLLINE REAGENT | Gds Diagnostics | 1989-05-16 | 53 | 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