Atlas FDA

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

Medcad — Predicate Candidate Screening

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

265 daysmedian FDA review time
443 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252064MedCAD® AccuStride™ SystemMedcad2026-03-272690
K251709MedCAD® AccuStride™ SystemMedcad2025-11-041540
K241811MedCAD® AccuStride™ SystemMedcad2025-03-132650
K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad2023-09-262220
K223421MedCAD AccuPlan Orthopedics SystemMedcad2023-09-203140
K223024MedCAD AccuPlan SystemMedcad2023-03-071590
K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad2022-08-261990
K193280MedCAD® AccuPlate® Patient-Specific PlateMedcad2021-02-124430
K192282MedCAD® AccuPlan® SystemMedcad2020-10-294340

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