# K083021: Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 29, 2008 after 20 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922933 (1992). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020997: Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, Dideco S.P.A. (2002) Summary page 1.
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator, Dideco S.P.A. (2002) Summary page 1.

## Most influential descendants
- 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
- K223879: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (2023), 0 descendants of its own

## Recalls of this device
- Dec 2, 2011 · Not classified · Z-0764-2012: 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-
- Dec 2, 2011 · Not classified · Z-0765-2012: 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 HP MPh.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Source page: https://510kreport.com/device/K083021
Methodology: https://510kreport.com/methodology