510(k) · Cleared

Cleared

Physioflow Enduro

K103283510(k) SpecialCleared Dec 3, 201028-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vasocom, Inc. · DSB Plethysmograph, Impedance

Cleared on Dec 3, 2010 as substantially equivalent to K060387 (Vasocom, Inc., 2008) after a 28-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.

Decided: Dec 3, 2010
Review: 28 days
Class: Class II
Product code: DSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K972320 (1997). 6 ancestors in all, the oldest K962424 (1996). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
3 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
2 generations backK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
1 generation backK060387 Physioflow SystemVasocom, Inc. · 2008
This deviceK103283 Physioflow EnduroVasocom, Inc. · 2010
Descendant · cites it directly · 2 of its ownK140102 Physioflow Q-LinkVasocom, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK172457 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018
Descendant · 2 generations on · 0 of its ownK173156 Integrated CardioRespiratory SystemSensydia, Inc. · 2018

Most influential descendants

Showing 3 of 3 · See all

K140102Physioflow Q-LinkVasocom, Inc. · 2014 · cites it directly2descendants
K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited · 2018 · 2 generations on0descendants
K173156Integrated CardioRespiratory SystemSensydia, Inc. · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K972320	Bioz System & Bioz Portable	Cardiodynamics International Corp.	1997	—
−3	K974725	Bioz.Com System	Cardiodynamics International Corp.	1998	—
−2	K041434	C3 and Lifegard Icg Impedance Cardiography Monitors	Analogic Corp.	2004	—
−1	K060387	Physioflow System	Vasocom, Inc.	2008	—
0 (this device)	K103283	Physioflow Enduro	Vasocom, Inc.	2010	—
+1	K140102	Physioflow Q-Link	Vasocom, Inc.	2014	—
+2	K172457	Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM	Deltex Medical Limited	2018	—
+2	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
2014	1	0
2018	2	0

FIG. 1 — Lineage of K103283, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K060387	Physioflow System Summary page 1 …de: DBS (plethysmograph, impedance) Class 11 Predicate Device Identification: PhysioFlow System Model PFO5 (K060387) Device Description: The PhysioFlow Enduro Model PF07 is a noninvasive, hemodynamic monitor that utilizes thoracic electrical…	Vasocom, Inc.	2008	—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140102	Physioflow Q-Link	Vasocom, Inc.	2014	2

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 13 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K140102 (Vasocom, Inc., 2014) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DSB

3in 2025

2007high 6 (2008) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSB

266in 2025

2007high 266 (2025) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSB

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSB

2in 2025

2007high 2 (2025) · low 0 (2007)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 Enduro PF07 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 LCWI Left Cardiac Work Index PEP Pre-Ejection Period SV Stroke Volume SVR Systemic Vascular Resistance SVRI Systemic Vascular Resistance Index…

Read the full statement (113 words)

Indicated for use in adults only.

The PhysioFlow Enduro PF07 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

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 Enduro System Model PF-07 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/K103283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103283: Physioflow Enduro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103283

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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