Atlas FDA

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

Silver Bay, LLC — Predicate Candidate Screening

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

257 daysmedian FDA review time
487 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112362C100 WRINKLE REDUCTION DEVICESilver Bay, LLC2012-08-143630
K111286QUASAR CALYPSOSilver Bay, LLC2012-01-182570
K091467BABY QUASARSilver Bay, LLC2010-09-174870
K093963QUASAR BLUE LIGHT THERAPY SYSTEMSilver Bay, LLC2010-08-272470
K072767QUASAR BLUE LIGHT THERAPY SYSTEMSilver Bay, LLC2007-10-15170

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