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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Playtex Family Products, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
269 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K941196PLATEX TAMPONS MODEL NUMBER 07094Playtex Family Products, Inc.1994-04-19360
K940821PLAYTEX TAMPONS #04994 UNSCENTED & SCENTEDPlaytex Family Products, Inc.1994-03-25310
K932907PLAYTEX ULTIMATES TAMPONSPlaytex Family Products, Inc.1994-03-072640
K932909PLAYTEX ULTIMATES TAMPONSPlaytex Family Products, Inc.1994-03-072640
K934083PLAYTEX ULTIMATES TAMPONSPlaytex Family Products, Inc.1994-03-071990
K935276PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONSPlaytex Family Products, Inc.1994-03-071240
K936189PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTEDPlaytex Family Products, Inc.1994-03-07700
K922834TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCYPlaytex Family Products, Inc.1993-09-014460
K924279PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +Playtex Family Products, Inc.1993-05-212690
K914438PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONSPlaytex Family Products, Inc.1992-01-02900
K912002PLAYTEX NON-DEODORANT/DEODORANT TAMPONSPlaytex Family Products, Inc.1991-08-12980
K904937PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONSPlaytex Family Products, Inc.1991-03-151340
K905378PLAYTEX NON-DEODORANT AND DEODORANT TAMPONSPlaytex Family Products, Inc.1991-02-11730
K897012SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONSPlaytex Family Products, Inc.1989-12-2220
K893725PLAYTEX TAMPONS, NON-DEODORANT/DEODORANTPlaytex Family Products, Inc.1989-08-04790
K891297PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONSPlaytex Family Products, Inc.1989-06-08870
K884737PLAYTEX NON-DEODORANT AND DEODORANT TAMPONSPlaytex Family Products, Inc.1989-01-10570

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