# K014080: Apex Adult Hollowe Fiber Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Dideco S.P.A.
- Decided: Jan 8, 2002 after 28 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dideco D 903 Avant Adult Hollow Fiber Oxygenator: named in the summary without a submission number

## Most influential descendants
- K020997: Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (2002), 5 descendants of its own
- K083021: Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator (2008), 4 descendants of its own
- K092895: Apex HP M Adult Hollow Fiber Membrane Oxygenator (2009), 3 descendants of its own
- K212688: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (2022), 2 descendants of its own
- K220110: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (2022), 1 descendant of its own

## Recalls of this device
- Dec 2, 2011 · Not classified · Z-0760-2012: Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-

## Indications for use
The Apex Hollow fiber membrane oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.

Source page: https://510kreport.com/device/K014080
Methodology: https://510kreport.com/methodology