# K163381: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 14, 2017 after 134 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K000126 (2000). 26 ancestors in all.
41 later devices descend from it; 1 cites it directly.
1 of 68 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043103: Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2, Edwards Lifesciences, LLC (2004) Summary page 4.
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform, Edwards Lifesciences, LLC (2016) Summary page 4.

## Most influential descendants
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable (2018), 40 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), 27 descendants of its own
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (2021), 18 descendants of its own
- K211465: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (2021), 15 descendants of its own

## Recalls of this device
- Oct 7, 2019 · Class II · Z-1928-2020: Intermittent communication due to inconsistent crimping of connectors onto cables.
- Oct 2, 2017 · Class II · Z-0496-2018: Pre-procedural issues related to software defects

## Indications for use
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

Source page: https://510kreport.com/device/K163381
Methodology: https://510kreport.com/methodology