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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Playtex, Inc. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

56 daysmedian FDA review time
146 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDPlaytex, Inc.2012-06-211460
K980478PLAYTEX TAMPONS #03498Playtex, Inc.1998-04-03560
K971174PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONSPlaytex, Inc.1997-05-21510
K944064PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894Playtex, Inc.1995-02-091740
K941044PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194Playtex, Inc.1994-07-271420
K942418PLAYTEX TAMPONS MODEL 13794Playtex, Inc.1994-07-08490
K881057PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPERPlaytex, Inc.1988-03-22110
K874509PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABELPlaytex, Inc.1988-01-07660
K843551PLAYTEX BABY POWDER DEODORANT TAMPONSPlaytex, Inc.1984-12-03840
K841154PLAYTEX SLENDER REGULAR TAMPONSPlaytex, Inc.1984-03-1900
K841155DEODORANT SLENDER REG. TAMPONSPlaytex, Inc.1984-03-1900
K830966PLAYTEX TAMPONSPlaytex, Inc.1983-04-08110
K812870IMPROVED PLAYTEX TAMPONPlaytex, Inc.1981-10-29150
K812534IMPROVED PLAYTEX TAMPONPlaytex, Inc.1981-09-21180
K811387PLAYTEX COMBINATION FIBER MODIFIED TAMPPlaytex, Inc.1981-08-07810
K811385PLAYTEX DIGITAL TAMPONPlaytex, Inc.1981-08-07810
K811388PLAYTEX COTTON DIGITAL TAMPONPlaytex, Inc.1981-08-07810
K811389PLAYTEX COTTON TAMPONSPlaytex, Inc.1981-08-07810
K811660PLAYTEX MODIFIED FIBER TAMPONSPlaytex, Inc.1981-07-16340
K811386PLAYTEX PROCESS MACHINERY CHANGEPlaytex, Inc.1981-07-10530

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