# K984322: Dideco D920, Lilliput 1 Twin Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Dideco S.P.A.
- Decided: Mar 2, 1999 after 89 days
- Product code: DTP (Defoamer, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4230
- 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 K941215 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941215: Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir, Sorin Biomedical, Inc. (1995) Summary page 1.
- K953976: Safe Micro, Polystan A/S (1997) Summary page 2.

## Indications for use
The Dideco D920, Lilliput 1 twin reservoir is intended for use in infants who underge cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuum-assisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir, as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return. Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

Source page: https://510kreport.com/device/K984322
Methodology: https://510kreport.com/methodology