# K990103: Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and 1200 Softshe

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Nov 5, 1999 after 297 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 K922933 (1992). 2 ancestors in all.
33 later devices descend from it; 1 cites it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922933: Sorin Monolyrh Integrated Membrane Lung, Sorin Biomedica, Fiat, USA, Inc. (1992) Summary page 2.
- K933481: Sorin Monolyth Venous Reservoir, Sorin Biomedical, Inc. (1993) Summary page 2.

## Most influential descendants
- K031223: Synthesis Mimesys Adult Membrane Oxygenator (2003), 32 descendants of its own
- K073380: Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/Cariotomy Reservoi (2008), 27 descendants of its own
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 (2009), 21 descendants of its own
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000 (2009), 12 descendants of its own
- K093522: Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/ Integrated Arterial Filter W/ Bioline C (2009), 8 descendants of its own

## Indications for use
The MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. The device provides oxygenation and removal of carbon dioxide from venous or suctioned blood. The integral heat exchanger provides blood temperature control, allows for the use of hypothermia, or aids in the maintenance of normothermia during surgery. The integral softshell venous reservoir is intended for use as a storage reservoir for blood. The device is indicated for use with blood flows of 1.0 to 8.0 liters per minute (LPM). The MONOLYTH C 600 and the MONOLYTH C 1200 have been tested for 6 hours of continuous use. Use longer than 6 hours is not advised.

Source page: https://510kreport.com/device/K990103
Methodology: https://510kreport.com/methodology