Atlas FDA

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

Portavision Medical, LLC · Predicate Candidate Screening

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

64 daysmedian FDA review time
152 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC2021-09-24420
K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC2021-06-24640
K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC2019-09-04900
K133524PVMED DDR 2430TPortavision Medical, LLC2014-04-161520
K083048NEORAY DR 2520 DIGITAL IMAGING SYSTEMPortavision Medical, LLC2008-11-21380

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