Atlas FDA

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

Lucenxia Prescience AG · Predicate Candidate Screening

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

154 daysmedian FDA review time
194 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173304Finessis Intense Polyisoprene Surgical GloveLucenxia Prescience AG2018-04-301940
K173386Finessis Zero Flexylon Powder Free Sterile White Surgical GlLucenxia Prescience AG2018-04-091610
K171987Finessis Zero Flexylon Powder Free Sterile White Surgical GlLucenxia Prescience AG2017-10-201090
K162852Finessis Zero Chemo Flexylon Powder Free Sterile White SurgiLucenxia Prescience AG2017-02-081200
K151607Finessis Zero Flexylon Powder Free Sterile White Surgical GlLucenxia Prescience AG2015-11-161540
K151605Finessis Corium Flexylon Powder Free Sterile Green Surgical Lucenxia Prescience AG2015-11-161540
K131751FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGLucenxia Prescience AG2013-09-251030
K123629FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVESLucenxia Prescience AG2013-05-131710
K123628STERILE LATEX SURGICAL GLOVELucenxia Prescience AG2013-03-181150

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