Atlas FDA

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

DTZ — Predicate Candidate Screening

254 FDA 510(k) clearances under this product code; the 50 most recent screened below.

88 daysmedian FDA review time
295 days90th percentile
254clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.2026-03-161050
K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Spectrum Medical S.R.L.2026-03-127060
K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATEurosets S.R.L2025-12-122690
K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter Eurosets S.R.L2025-11-244590
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum PerfusioQura S.R.L2024-09-124350
K240666Affinity Fusion Oxygenator with Integrated Arterial Filter aMedtronic Perfusion Systems2024-07-101240
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous ReserMedtronic, Inc.2024-06-12301
K231652D100 KIDS; D101 KIDSSorin Group Italia S.R.L.2023-11-161630
K231773Quantum Perfusion Blood Oxygenator with Integrated AF and SeQura S.R.L2023-11-081450
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical , Ltd.2023-11-011690
K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.2023-04-06290
K223161OXY-1 SystemAbiomed, Inc.2023-02-231390
K222297CentriMag Pre-connected PackAbbott2022-12-011220
K212341Quantum Perfusion Blood Oxygenator with Integrated AF and SeQura S.R.L2022-01-281840
K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum PerQura S.R.L2021-12-173920
K202510AMG PMP InfantEurosets S.R.L2021-12-104660
K203111Affinity Fusion Oxygenator System, Affinity Pixie OxygenatioMedtronic2021-09-163366
K211495EOS PMPSorin Group Italia S.R.L.2021-07-12600
K202206AMG PMP PediatricEurosets S.R.L2021-04-012390
K200109OXY-1 SystemAbiomed, Inc.2020-10-232801
K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical , Ltd.2020-09-18930
K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber Sorin Group Italia S.R.L.2020-08-13340
K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterialSorin Group Italia S.R.L.2020-06-12880
K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical , Ltd.2020-02-282950
K191444Affinity NT Oxygenator with Balance Biosurface, Affinity NT Medtronic, Inc.2019-09-271190
K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow FiMedtronic, Inc.2019-05-17290
K190690INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Sorin Group Italia S.R.L.2019-04-13260
K183490Affinity NT Oxygenator, Affinity NT Oxygenator with TrilliumMedtronic, Inc.2019-04-121160
K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BMedtronic, Inc.2019-03-189010
K180950Terumo Capiox NX19 Oxygenator with Reservoir (east OrientatiTerumo Cardiovascular Systems Corporation2018-06-22721
K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientatiTerumo Cardiovascular Systems Corporation2018-03-292620
K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow FibeSorin Group Italia S.R.L.2018-03-15300
K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Medtronic, Inc.2017-11-20540
K172626Affinity Fusion Oxygenator with Balance Biosurface, AffinityMedtronic, Inc.2017-10-25540
K162896Affinity NT Oxygenator, Affinity NT Oxygenator with TrilliumMedtronic, Inc.2016-12-06500
K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc.2016-09-21620
K153295TandemLung OxygenatorCardiacassist, Inc.2016-02-261050
K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell ResTerumo Cardiovascular Systems Corporation2015-12-03280
K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo CTerumo Cardiovascular Systems Corp.2015-12-02330
K151791Terumo Capiox FX15 Advance Oxygenator with Integrated ArteriTerumo Cardiovascular Systems Corporation2015-11-191411
K151713LILLIPUP PMP, LILLIPUT PMP INTEGRATEDSorin Group Italia S.R.L.2015-11-061340
K151389Terumo Capiox FX15 Advance Oxygenator with Integrated ArteriTerumo Cardiovascular Systems Corporation2015-10-201470
K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.2015-06-111060
K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxyMaquet Cardiopulmonary, AG2015-05-07921
K143073Affinity NT Oxygenator, Affinity NT Oxygenator with TrilliumMedtronic, Inc.2015-03-251490
K141492ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERIEurosets S.R.L2015-02-062460
K142784Affinity Fusion Oxygenator with Integrated Arterial Filter aMedtronic, Inc.2014-10-24281
K140774TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOITerumo Cardiovascular Systems Corporation2014-06-02660
K140181MEDOS HILITE INFANT OXYGENATORMedos Medizintechnik AG2014-02-19260
K140177MEDOS HILITE OXYGENATORMedos Medizintechnik AG2014-02-18250

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