510(k) · Cleared
ClearedIntegrated CardioRespiratory System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensydia, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 8, 2018 as substantially equivalent to K140102 (Vasocom, Inc., 2014) and 1 other predicate after a 252-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 8, 2018
- Review
- 252 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K972320 (1997). 11 ancestors in all, the oldest K962424 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 5 generations backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- 4 generations backK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- 3 generations backK060387 Physioflow SystemVasocom, Inc. · 2008
- 2 generations backK103283 Physioflow EnduroVasocom, Inc. · 2010
- 1 generation backK140102 Physioflow Q-LinkVasocom, Inc. · 2014
- This deviceK173156 Integrated CardioRespiratory SystemSensydia, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −5 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| −4 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| −3 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| −2 | K103283 | Physioflow Enduro | Vasocom, Inc. | 2010 | — |
| −1 | K140102 | Physioflow Q-Link | Vasocom, Inc. | 2014 | — |
| 0 (this device) | K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K140102 | Physioflow Q-LinkSummary page 5…ge 5 === K173156 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] • Primary predicate: Vasocom, Inc. Physioflow Q-Link (K140102) • Secondary predicate: Inovise Medical, Inc. Audicor, Hemo Ambulatory Monitor (K073545) DEVICE DESCRIPTION [807.9… | 2014 |
| * | K073545 | Audicor, Hemo Ambulatory MonitorSummary page 5…(a)(3)] • Primary predicate: Vasocom, Inc. Physioflow Q-Link (K140102) • Secondary predicate: Inovise Medical, Inc. Audicor, Hemo Ambulatory Monitor (K073545) DEVICE DESCRIPTION [807.92(a)(4)] The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and com… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K140102.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction. The ICR System is not intended as a sole means of…
Read the full statement (164 words)
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.
The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indicated for use in adults only. The ICR 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173156: Integrated CardioRespiratory System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173156
Report an extraction error
Are you the manufacturer?
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