Atlas FDA

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

Dazey Products Co. — Predicate Candidate Screening

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

16 daysmedian FDA review time
16 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K771966VIBRO BATH MODEL FS-1Dazey Products Co.1977-11-02160
K771969TURBO-JET MODEL 76Dazey Products Co.1977-11-02160
K771970WHIRLPOOL BATH MODEL 50Dazey Products Co.1977-11-02160
K771967WHIRLPOOL BATH MODEL 2270Dazey Products Co.1977-10-28110
K771968WHIRLPOOL BATH MODEL 2273Dazey Products Co.1977-10-28110
K771971HYDROMASSAGE EQUIP. MODEL 1000Dazey Products Co.1977-10-2140

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