Atlas FDA

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

Radiometer Medicals Aps — Predicate Candidate Screening

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

267 daysmedian FDA review time
273 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps2026-05-012660
K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps2026-05-012670
K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps2026-04-102700
K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps2025-01-142730
K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps2024-12-132460

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