510(k) · Cleared
ClearedPhysioflow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasocom, Inc. · DSB Plethysmograph, Impedance
Cleared on Apr 10, 2008 as substantially equivalent to K041434 (Analogic Corp., 2004) after a 786-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 10, 2008
- Review
- 786 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972320 (1997). 5 ancestors in all, the oldest K962424 (1996). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 2 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- 1 generation backK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- This deviceK060387 Physioflow SystemVasocom, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK103283 Physioflow EnduroVasocom, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK140102 Physioflow Q-LinkVasocom, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
- Descendant · 3 generations on · 0 of its ownK173156 Integrated CardioRespiratory SystemSensydia, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K103283Physioflow EnduroVasocom, Inc. · 2010 · cites it directly3descendants
- K140102Physioflow Q-LinkVasocom, Inc. · 2014 · 2 generations on2descendants
- K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018 · 3 generations on0descendants
- K173156Integrated CardioRespiratory SystemSensydia, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −2 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| −1 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| 0 (this device) | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| +1 | K103283 | Physioflow Enduro | Vasocom, Inc. | 2010 | — |
| +2 | K140102 | Physioflow Q-Link | Vasocom, Inc. | 2014 | — |
| +3 | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018 | — |
| +3 | K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K041434 | C3 and Lifegard Icg Impedance Cardiography MonitorsSummary page 1…emodynamic Monitor Classification Name Impedance plethysmograph (per 21 CFR 870.2770) Predicate Device Philips ICG 510(k) number K041434 (Formerly Analogic Corp.) 4/6/200… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103283 | Physioflow Enduro | 2010 | 3 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103283 (Vasocom, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K041434.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Indicated for use in adults only The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters. These parameters include: Cl Cardiac Index CO Cardiac Output CTI Contractility Index dZ / dTmax Maximum value dZ / dT EDV End Diastolic Volume EF Ejection Fraction HR Heart Rate LCWI Left Cardiac Work Index PEP Pre Ejection Period SV Stroke Volume SVR Systemic Vascular Resistance SVRI Systemic Vascular Resistance Index TFI…
Read the full statement (110 words)
Indicated for use in adults only
The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
Cl Cardiac Index
CO Cardiac Output
CTI Contractility Index
dZ / dTmax Maximum value dZ / dT
EDV End Diastolic Volume
EF Ejection Fraction
HR Heart Rate
LCWI Left Cardiac Work Index
PEP Pre Ejection Period
SV Stroke Volume
SVR Systemic Vascular Resistance
SVRI Systemic Vascular Resistance Index
TFI Thoracic Fluid Index
VET Ventricular Ejection Time
Zo Base Impedance
The PhysioFlow System 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060387: Physioflow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060387
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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