Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gradipore , Ltd. — 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) |
|---|---|---|---|---|---|
| K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP- | Gradipore , Ltd. | 2000-02-16 | 135 | 0 |
| K992456 | GRADILEIDEN V TEST | Gradipore , Ltd. | 1999-12-21 | 151 | 0 |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | 1993-04-06 | 334 | 0 |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | 1990-12-17 | 159 | 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