# K050447: Performa Adult Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Dideco S.R.L.
- Decided: Mar 8, 2005 after 14 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Apex Ph.I.S.I.O. Adult Hollow Fiber Oxygenator: named in the summary without a submission number

## Most influential descendants
- K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012 (2011), 4 descendants of its own
- K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) (2015), 3 descendants of its own
- K202206: AMG PMP Pediatric (2021), 1 descendant of its own
- K252541: Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (2026), 0 descendants of its own
- K202510: AMG PMP Infant (2021), 0 descendants of its own

## Recalls of this device
- Dec 2, 2011 · Not classified · Z-0768-2012: 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 Performa 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 up to 6 hours.

Source page: https://510kreport.com/device/K050447
Methodology: https://510kreport.com/methodology