Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Playtex, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
77 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871197 | PLAYTEX TAMPONS AND DEODORANT TAMPONS | Intl. Playtex, Inc. | 1987-05-12 | 49 | 0 |
| K861738 | PLAYTEX TAMPONS | Intl. Playtex, Inc. | 1986-07-22 | 77 | 0 |
| K854258 | PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA | Intl. Playtex, Inc. | 1985-11-21 | 30 | 0 |
| K852063 | PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS | Intl. Playtex, Inc. | 1985-05-22 | 9 | 0 |
| K851356 | PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS | Intl. Playtex, Inc. | 1985-04-12 | 8 | 0 |
| K851355 | PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS | Intl. Playtex, Inc. | 1985-04-12 | 8 | 0 |
| K782112 | PADS, MINI, MAXI | Intl. Playtex, Inc. | 1979-01-08 | 21 | 0 |
| K782111 | PADS, MINI, MAXI DEODORANT | Intl. Playtex, Inc. | 1979-01-08 | 21 | 0 |
| K760425 | TAMPON, PLAYTEX 2 VERSION A | Intl. Playtex, Inc. | 1976-09-13 | 32 | 0 |
| K760426 | TAMPON, PLAYTEX 2 VERSION B | Intl. Playtex, Inc. | 1976-08-26 | 14 | 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