Atlas FDA

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

Levita Magnetics International Corp — Predicate Candidate Screening

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

167 daysmedian FDA review time
489 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252435Magnetic Surgical SystemLevita Magnetics International Corp2025-09-26560
K250746Magnetic Surgical SystemLevita Magnetics International Corp2025-06-07870
K223673Surgeon Controlled ArmLevita Magnetics International Corp2023-08-042400
K191762Magnetic Surgical SystemLevita Magnetics International Corp2020-04-012750
K190006Magnetic Surgical SystemLevita Magnetics International Corp2019-04-291170
K180894Magnetic Surgical SystemLevita Magnetics International Corp2018-09-191670
K171429Magnetic Surgical SystemLevita Magnetics International Corp2017-06-06220
DEN150007Magnetic Surgical SystemLevita Magnetics International Corp2016-06-134890

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