510(k) · Cleared
ClearedPhysioflow Q-Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasocom, Inc. · DSB Plethysmograph, Impedance
Cleared on Feb 12, 2014 as substantially equivalent to K103283 (Vasocom, Inc., 2010) after a 28-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 12, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972320 (1997). 7 ancestors in all, the oldest K962424 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 4 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- 3 generations backK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- 2 generations backK060387 Physioflow SystemVasocom, Inc. · 2008
- 1 generation backK103283 Physioflow EnduroVasocom, Inc. · 2010
- This deviceK140102 Physioflow Q-LinkVasocom, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
- Descendant · cites it directly · 0 of its ownK173156 Integrated CardioRespiratory SystemSensydia, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −4 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| −3 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| −2 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| −1 | K103283 | Physioflow Enduro | Vasocom, Inc. | 2010 | — |
| 0 (this device) | K140102 | Physioflow Q-Link | Vasocom, Inc. | 2014 | — |
| +1 | K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM | Deltex Medical Limited | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103283 | Physioflow EnduroSummary page 1…code: DBS (plethysmograph, impedance) Class 11 Predicate Device Identification: PhysioFlow Enduro Model PF07 (K 103283) Device Description: The PhysioFlow Q-Link is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedan… | 2010 |
What descends from it? (2)
2 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 17 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172457 (Deltex Medical Limited, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Q-Link noninvasively measures cardiac output and other related cardiac parameters. These parameters include: CI Cardiac Index CO Cardiac Output CTI Contractility Index dZ / dt max Maximum value dZ / dt EDV End Diastolic Volume EF Ejection Fraction HR Heart Rate LCW1 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 Q-Link noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
CI Cardiac Index
CO Cardiac Output
CTI Contractility Index
dZ / dt max Maximum value dZ / dt
EDV End Diastolic Volume
EF Ejection Fraction
HR Heart Rate
LCW1 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 Q-Link 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/K140102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140102: Physioflow Q-Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140102
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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