Atlas FDA

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

Dideco — Predicate Candidate Screening

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

282 daysmedian FDA review time
395 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K004001MONOLYTH MIMESYS HOLLOW FIBER OXYGENATORDideco2001-10-042820
K010478DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUTDideco2001-09-272190
K001388DATA MASTER PERFUSION MONITORING SYSTEMDideco2000-07-28870
K936220DIDECO VACUUM PUMPDideco1995-01-273950
K940519DIDECO COMPACT-A AUTOTRANSFUSION SYSTEMDideco1995-01-193490

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