Atlas FDA

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

Playtime Products, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
335 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993794PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE Playtime Products, Inc.2000-02-07900
K981760PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONPlaytime Products, Inc.1998-07-22640
K964269PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/Playtime Products, Inc.1996-11-29350
K961456PLAYTEX TAMPONS #10296Playtime Products, Inc.1996-06-18630
K952394PLAYTEX TAMPONS #13695Playtime Products, Inc.1995-08-21910
K950928ULTIMATES SILK GLIDE TAMPONSPlaytime Products, Inc.1995-03-22210
K923375PLAYSKOOL SUNGLASSESPlaytime Products, Inc.1993-06-093350
K923374VARIOUS SUNGLASSESPlaytime Products, Inc.1993-06-093350

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