Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Glaxo, 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) |
|---|---|---|---|---|---|
| K954041 | G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONY | Glaxo, Inc. | 1995-10-16 | 48 | 0 |
| K922187 | COMPACT SPACER | Glaxo, Inc. | 1992-11-20 | 193 | 0 |
| K901803 | SYRINGE NEEDLE INTRODUCER | Glaxo, Inc. | 1990-11-20 | 215 | 0 |
| K844169 | VOLUMATIC | Glaxo, Inc. | 1984-11-09 | 15 | 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