# K041434: C3 and Lifegard Icg Impedance Cardiography Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corp.
- Decided: Aug 6, 2004 after 70 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972320 (1997). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030931: C3 Patient Monitor, Analogic Corp. (2003) Summary page 3.
- K974725: Bioz.Com System, Cardiodynamics International Corp. (1998) Summary page 1.

## Most influential descendants
- K060387: Physioflow System (2008), 4 descendants of its own
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 (2007), 4 descendants of its own
- K103283: Physioflow Enduro (2010), 3 descendants of its own
- K140102: Physioflow Q-Link (2014), 2 descendants of its own
- K090602: Cardiodynamics Bioz RX, Model 7101-Sys (2009), 1 descendant of its own

## Indications for use
The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include: Acceleration Index (ACI) Pre-ejection Period (PEP) Cardiac Index (CI) Stroke Index (SI) Cardiac Output (CO) Stroke Volume (SV) Ejection Time Ratio (ETR) Systemic Vascular Resistance (SVR) Ejection Velocity Index (EVI) Systemic Vascular Resistance Index (SVRI) Heart Rate (HR) Systolic Time Ratio (STR) Heather Index (HI) Thoracic Fluid Content (TFC) Left Cardiac Work Index (LCWI) Thoracic Fluid Volume Index (TFI) Left-ventricular Ejection Time (LVET) Velocity Index (VI) The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare. The C3 ICG is intended for use on Adult patients that meet the limits specified below: Height: 4 ft -7 ft-6 in (122-229 cm) Weight: 67 - 350 lb (30 - 159 kg) When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care. These are indications previously cleared under K030931. The LIFEGARDTM ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include: Acceleration Index (ACI) Stroke Index (SI) Blood Pressure (built-in NIBP) Stroke Volume (SV) Cardiac Index (CI) Systemic Vascular Resistance (SVR) Cardiac Output (CO) Systemic Vascular Resistance Index (SVRI) Heart Rate (HR) Systolic Time Ratio (STR) Left Cardiac Work Index (LCWI) Thoracic Fluid Content (TFC) Left-ventricular Ejection Time (LVET) Velocity Index (VI) Pre-ejection Period (PEP) The LIFEGARDTM ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare. The LIFEGARDTM ICG is intended for use on Adult patients that meet the limits specified below: Height: 4 ft-7 ft-6 in (122-229 cm) Weight: 67 - 350 lb (30 - 159 kg)

Source page: https://510kreport.com/device/K041434
Methodology: https://510kreport.com/methodology