# K922933: Sorin Monolyrh Integrated Membrane Lung

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedica, Fiat, USA, Inc.
- Decided: Nov 30, 1992 after 165 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
No predicates in its family tree.
86 later devices descend from it; 3 cite it directly.
3 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980600: D903 Avant Adult Hollow Fiber Oxygenator (1998), 73 descendants of its own
- K020351: D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator (2002), 72 descendants of its own
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy (2002), 35 descendants of its own
- K990103: Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and 1200 Softshe (1999), 33 descendants of its own
- K031223: Synthesis Mimesys Adult Membrane Oxygenator (2003), 32 descendants of its own

Source page: https://510kreport.com/device/K922933
Methodology: https://510kreport.com/methodology