# K092895: Apex HP M Adult Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 19, 2009 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
Longest line of descent: 5 generations back to K922933 (1992). 8 ancestors in all.
3 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)
- K014080: Apex Adult Hollowe Fiber Oxygenator, Dideco S.P.A. (2002) Summary page 2.
- K083021: Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, Sorin Group Italia S.R.L. (2008) Summary page 2.

## Most influential descendants
- 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-0763-2012: 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 M 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/K092895
Methodology: https://510kreport.com/methodology