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

Scientia Vascular, LLC — Predicate Candidate Screening

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

67 daysmedian FDA review time
392 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24Scientia Vascular, LLC2023-03-103920
K210601Plato 17 MicrocatheterScientia Vascular, LLC2021-04-28581
K201760Zoom 14 GuidewireScientia Vascular, LLC2020-07-29300
K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 GScientia Vascular, LLC2019-10-30300
K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 GScientia Vascular, LLC2019-03-22860
K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 2Scientia Vascular, LLC2018-08-07290
K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 GuScientia Vascular, LLC2018-01-221090
K170406Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC2017-04-18670
K143398Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC2015-06-262120
K121734PLATO MICROCATH 27 MICROCATHETERScientia Vascular, LLC2012-07-30470

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