# K202510: AMG PMP Infant

- Pathway: 510(k) (Traditional)
- Applicant: Eurosets S.R.L
- Decided: Dec 10, 2021 after 466 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: 8 generations back to K922933 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151713: Lillipup PMP, Lilliput PMP Integrated, Sorin Group Italia S.R.L. (2015) Summary page 4.
- K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile), Eurosets S.R.L (2015) Summary page 4.

## Indications for use
The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants.

Source page: https://510kreport.com/device/K202510
Methodology: https://510kreport.com/methodology