Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Glaxosmithkline Consumer Healthcare (Gskch) · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOT | Glaxosmithkline Consumer Healthcare (Gskch) | 2013-01-04 | 30 | 1 |
| K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIE | Glaxosmithkline Consumer Healthcare (Gskch) | 2011-07-20 | 209 | 0 |
| K101477 | BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH | Glaxosmithkline Consumer Healthcare (Gskch) | 2010-09-28 | 123 | 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