Atlas FDA

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

Products For Medicine · Predicate Candidate Screening

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

77 daysmedian FDA review time
105 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963227WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175Products For Medicine1996-10-23650
K955510X6000D SILENT SUN LIGHT SOURCEProducts For Medicine1996-01-31580
K953089I-SPOUSEProducts For Medicine1995-10-161050
K951703TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATProducts For Medicine1995-06-28770
K951704NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATIONProducts For Medicine1995-06-28770
K883658I-SPOSE EYE SHIELDProducts For Medicine1988-10-25600

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