# K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Eurosets S.R.L
- Decided: Feb 6, 2015 after 246 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: 7 generations back to K922933 (1992). 13 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012, Eurosets S.R.L (2011) Summary page 6.

## Most influential descendants
- 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 Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) 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 Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) 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.

Source page: https://510kreport.com/device/K141492
Methodology: https://510kreport.com/methodology