Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Lil Drug Store Products, Inc. · 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) |
|---|---|---|---|---|---|
| K101098 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUS | Lil Drug Store Products, Inc. | 2010-08-17 | 119 | 0 |
| K101241 | REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICA | Lil Drug Store Products, Inc. | 2010-08-17 | 105 | 0 |
| K072414 | CRYOSTAT | Lil Drug Store Products, Inc. | 2008-04-07 | 223 | 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