Atlas FDA

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

X-Nav Technologies, LLC — Predicate Candidate Screening

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

217 daysmedian FDA review time
251 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2024-02-212172
K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2022-02-012431
K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC2020-05-21690
K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2020-02-031370
K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2015-10-082510

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