Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Playtex Manufacturing, 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) |
|---|---|---|---|---|---|
| K180167 | Playtex Stella Tampons | Playtex Manufacturing, Inc. | 2018-05-30 | 128 | 0 |
| K132819 | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | Playtex Manufacturing, Inc. | 2013-10-09 | 30 | 0 |
| K111684 | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | Playtex Manufacturing, Inc. | 2012-02-03 | 233 | 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