Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Playtex Products, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
174 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPO | Playtex Products, Inc. | 2008-01-17 | 22 | 0 |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | 2007-12-12 | 110 | 0 |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTL | Playtex Products, Inc. | 2007-04-13 | 25 | 0 |
| K061013 | PLAYTEX EMBRACE PETITE BREAST PUMP | Playtex Products, Inc. | 2006-08-15 | 124 | 1 |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPO | Playtex Products, Inc. | 2006-05-09 | 29 | 0 |
| K032636 | PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORE | Playtex Products, Inc. | 2003-11-14 | 79 | 0 |
| K022594 | PLAYTEX BREAST PUMP | Playtex Products, Inc. | 2002-11-01 | 88 | 0 |
| K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | Playtex Products, Inc. | 2002-09-16 | 17 | 0 |
| K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Playtex Products, Inc. | 2002-03-13 | 50 | 0 |
| K020202 | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Playtex Products, Inc. | 2002-03-12 | 49 | 0 |
| K020201 | PLAYTEX DEODORANT TAMPONS, MODEL 34902 | Playtex Products, Inc. | 2002-03-12 | 49 | 0 |
| K982383 | PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND | Playtex Products, Inc. | 1998-08-19 | 42 | 0 |
| K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIM | Playtex Products, Inc. | 1997-09-26 | 120 | 0 |
| K971547 | PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT A | Playtex Products, Inc. | 1997-06-19 | 52 | 0 |
| K961870 | PLAYTEX SLIMFIT TAMPONS | Playtex Products, Inc. | 1996-06-19 | 40 | 0 |
| K944155 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094 | Playtex Products, Inc. | 1995-02-09 | 174 | 0 |
| K944154 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994 | Playtex Products, Inc. | 1995-02-09 | 174 | 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