Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laclede, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
210 daysmedian FDA review time
274 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing G | Laclede, Inc. | 2024-04-19 | 58 | 0 |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | 2018-10-11 | 210 | 0 |
| K162235 | LUVENA VAGINAL MOISTURIZER & LUBRICANT | Laclede, Inc. | 2017-03-24 | 227 | 0 |
| K150841 | Luvena Enhanced Personal Moisturizer, Luvena Enhanced Person | Laclede, Inc. | 2015-12-29 | 274 | 0 |
| K061331 | ORAL BALANCE LIQUID/ GEL | Laclede, Inc. | 2006-07-25 | 74 | 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