Atlas FDA

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

Orbus Medical Technologies — Predicate Candidate Screening

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

134 daysmedian FDA review time
200 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041370LIFESTENT LP SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies2004-06-24310
K041032MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHEOrbus Medical Technologies2004-05-10190
K040550LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies2004-03-16140
K033212LIFESTENT SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies2003-10-30270
K023308LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIAOrbus Medical Technologies2003-04-141930
K023121LIFESTENT BILIARY ENDOPROSTHESISOrbus Medical Technologies2003-03-101720
K023248LIFESTENT LP SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies2003-02-111341
K010107R STENT BILIARY ENDOPROSTHESISOrbus Medical Technologies2001-07-312000

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