Atlas FDA

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

Windmere Corp. — Predicate Candidate Screening

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

173 daysmedian FDA review time
420 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980769WINDMERE MODEL DS-2 FOOT BATHWindmere Corp.1998-03-27280
K932904WINDMERE WAND MASSAGERWindmere Corp.1994-02-172460
K933974WINDMERE MASSAGE MATEWindmere Corp.1994-02-021730
K924237WINDMERE PRELUDE IIIWindmere Corp.1993-10-184200
K931086WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGERWindmere Corp.1993-09-302110
K912659SOUND RELIEFWindmere Corp.1991-09-06810
K896245PLAK TRAC POWERED TOOTHBRUSHWindmere Corp.1990-03-281490

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