Atlas FDA

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

Phasor Health, LLC · Predicate Candidate Screening

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

122 daysmedian FDA review time
245 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252696LEGACYPhasor Health, LLC2025-11-21860
K252514EVAC-MRIPhasor Health, LLC2025-11-05860
K252060GREENPhasor Health, LLC2025-10-311220
K250505EZ-FIDUCIALSPhasor Health, LLC2025-07-091380
K243205EVACPhasor Health, LLC2025-06-032450

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