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

Vanaray Laboratories, Inc. — Predicate Candidate Screening

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

64 daysmedian FDA review time
81 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802647ECA GEL PROUDUCT REFORMULATIONVanaray Laboratories, Inc.1981-01-08800
K802648UCA CREAM PRODUCT REFORMULATIONVanaray Laboratories, Inc.1980-11-26370
K802649UCA GEL PRODUCT REFORMAULATIONVanaray Laboratories, Inc.1980-11-12230
K802650UCA LOTION PRODUCT REFORMULATIONVanaray Laboratories, Inc.1980-11-12230
K801383ECA CREAM REFORMULATIONVanaray Laboratories, Inc.1980-06-1760
K792490UCA LOTIONVanaray Laboratories, Inc.1980-02-22810
K792489UCA CREAMVanaray Laboratories, Inc.1980-02-05640
K792488ECA GELVanaray Laboratories, Inc.1980-02-05640
K792491ECA CREAMVanaray Laboratories, Inc.1980-02-05640
K792492UCA GELVanaray Laboratories, Inc.1980-02-05640

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