Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GLG — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842921 | REES & ECKER DILUTION FLUID | E K Ind., Inc. | 1984-09-07 | 44 | 0 |
| K811084 | LABTRONIX PLATELET COUNTER(L/O/C.) | Labtronix Corp. | 1981-07-23 | 93 | 0 |
| K772105 | PLATELET KIT | Streck Laboratories, Inc. | 1977-11-30 | 23 | 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