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

Dideco S.P.A. — Predicate Candidate Screening

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

74 daysmedian FDA review time
176 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSDideco S.P.A.2004-05-06130
K033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 Dideco S.P.A.2004-01-13901
K033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTDideco S.P.A.2004-01-08160
K033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHDideco S.P.A.2003-12-11150
K032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENDideco S.P.A.2003-07-0981
K031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATORDideco S.P.A.2003-05-02140
K030154IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGADideco S.P.A.2003-03-31740
K021732DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATDideco S.P.A.2002-11-041640
K022450INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH IDideco S.P.A.2002-10-22880
K020647DIDECO ELECTADideco S.P.A.2002-09-051892
K020997APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATORDideco S.P.A.2002-04-0472
K020351D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATORDideco S.P.A.2002-02-26220
K014080APEX ADULT HOLLOWE FIBER OXYGENATORDideco S.P.A.2002-01-08281
K013915D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECDideco S.P.A.2001-12-27300
K001602DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSEDideco S.P.A.2000-06-08150
K001021LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.SDideco S.P.A.2000-04-25260
K991737LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.SDideco S.P.A.2000-02-172721
K992599DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIRDideco S.P.A.1999-11-01900
K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.1999-03-02890
K982650AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)Dideco S.P.A.1998-12-161392
K980600D903 AVANT ADULT HOLLOW FIBER OXYGENATORDideco S.P.A.1998-08-121760
K971877LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATORDideco S.P.A.1997-10-081400

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