# K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012

- Pathway: 510(k) (Traditional)
- Applicant: Eurosets S.R.L
- Decided: Feb 15, 2011 after 202 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922933 (1992). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050447: Performa Adult Hollow Fiber Membrane Oxygenator, Dideco S.R.L. (2005) Summary page 2.
- K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi, Sorin Group Italia S.R.L. (2008) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir. The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. AMG is a single use device.

Source page: https://510kreport.com/device/K102109
Methodology: https://510kreport.com/methodology