510(k) · Cleared
ClearedC3 and Lifegard Icg Impedance Cardiography Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corp. · DSB Plethysmograph, Impedance
Cleared on Aug 6, 2004 as substantially equivalent to K030931 (Analogic Corp., 2003) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1997. 11 later devices descend from it.
- Decided
- Aug 6, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972320 (1997). 4 ancestors in all, the oldest K962424 (1996). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 1 generation backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- This deviceK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- Descendant · cites it directly · 4 of its ownK060387 Physioflow SystemVasocom, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
- Descendant · 2 generations on · 3 of its ownK103283 Physioflow EnduroVasocom, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK140102 Physioflow Q-LinkVasocom, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060387Physioflow SystemVasocom, Inc. · 2008 · cites it directly4descendants
- K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · cites it directly4descendants
- K103283Physioflow EnduroVasocom, Inc. · 2010 · 2 generations on3descendants
- K140102Physioflow Q-LinkVasocom, Inc. · 2014 · 3 generations on2descendants
- K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −1 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| 0 (this device) | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| +1 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| +1 | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 | Cardiodynamics International Corp. | 2007 | — |
| +2 | K103283 | Physioflow Enduro | Vasocom, Inc. | 2010 | — |
| +3 | K140102 | Physioflow Q-Link | Vasocom, Inc. | 2014 | — |
| +2 | K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | Cardiodynamics International Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030931 | C3 Patient MonitorSummary page 3…uch as clinics. Comparison of Technological Characteristics: The design of the C3 ICG Monitor is a product update to the design of the C3 Patient Monitor (K03093 1). The technological characteristics of the C3 ICG are essentially the same as the predicate device - Cardiodynamics BioZ (… | 2003 |
| * | K974725 | Bioz.Com SystemSummary page 1…equivalence is being claimed are: The C3 Patient Monitor cleared under K030903 1, and the Cardiodynamics BioZ System cleared under Premarket Notification K974725. The Impedance Cardiography (ICG) parameter incorporated in the C3 ICG and LIFEGARDTM ICG is substantially equivalent to… | 1998 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060387 (Vasocom, Inc., 2008) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K030931.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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)…
Read the full statement (343 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041434: C3 and Lifegard Icg Impedance Cardiography Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041434
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026