Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Contract Medical International, GmbH · Predicate Candidate Screening

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

68 daysmedian FDA review time
304 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Contract Medical International, GmbH2025-03-16300
K240957Catapult Guide SheathContract Medical International, GmbH2024-08-141280
K221914Catapult Guide SheathContract Medical International, GmbH2022-07-29290
K203179Fortress Introducer Sheath SystemContract Medical International, GmbH2020-11-20250
K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH2018-12-131920
K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH2016-01-11681
K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH2015-06-253040

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