# K151713: Lillipup PMP, Lilliput PMP Integrated

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 6, 2015 after 134 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: 1 generation back to K001021 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001021: Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.) Infant Hollow Fibre Oxygenator, Model D902, Dideco S.P.A. (2000) Summary page 4.

## Most influential descendants
- K202510: AMG PMP Infant (2021), 0 descendants of its own

## Indications for use
The device is intended for use in infants not exceeding 20 Kg (44 lb) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K151713
Methodology: https://510kreport.com/methodology