Atlas FDA

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

Mag & More GmbH — Predicate Candidate Screening

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

268 daysmedian FDA review time
279 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH2026-05-22920
K243700Apollo TMS Therapy SystemMag & More GmbH2025-09-042790
K243539Apollo TMS Therapy SystemMag & More GmbH2025-08-182760
K232639Apollo TMS Therapy SystemMag & More GmbH2024-05-242680
K180313Apollo TMS Therapy SystemMag & More GmbH2018-05-04880

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