Atlas FDA

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

Allengers Medical Systems Limited · Predicate Candidate Screening

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

135 daysmedian FDA review time
249 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253296Digital C-ARM with 3DAllengers Medical Systems Limited2026-06-052490
K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited2025-04-181350
K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited2022-11-27590
K223060DigiX FDXAllengers Medical Systems Limited2022-10-26260
K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited2022-05-03900
K200218Digiscan FDXAllengers Medical Systems Limited2020-07-131670
K192541DigiX FDXAllengers Medical Systems Limited2019-10-16300
K162529DigiX FDXAllengers Medical Systems Limited2017-03-031750

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