# K043065: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1P

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 26, 2005 after 82 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO₂/CEDV) Monitor: named in the summary without a submission number
- (no number) Metracor RODA Monitoring System: named in the summary without a submission number
- (no number) Phoenix Disposable Pressure Transducer: named in the summary without a submission number

## Most influential descendants
- K152980: Flo Trac sensor, Volume View sensor (2016), 7 descendants of its own
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (2023), 6 descendants of its own
- K101518: Compass Vascular Access; Compass Lumbar Puncture (2010), 6 descendants of its own
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K112203: Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist (2011), 4 descendants of its own

## Recalls of this device
- Jul 31, 2013 · Class II · Z-2189-2013: The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of be

## Indications for use
The Vigileo APCO/Oximetry monitor is indicated for use for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. The Pressure Monitoring Kit with TruWave dual disposable pressure transducer is indicated for use in intravascular pressure monitoring. It is also indicated for use with Edwards pulse pressure based cardiac output monitoring devices or hardware to measure cardiac output.

Source page: https://510kreport.com/device/K043065
Methodology: https://510kreport.com/methodology