510(k) · Cleared
ClearedTransonic HCM 103 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transonic Systems, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Sep 17, 2014 as substantially equivalent to K082308 (Edwards Lifesciences, LLC, 2008) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Sep 17, 2014
- Review
- 260 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K062134 (2006). 3 ancestors in all, the oldest K010049 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- 1 generation backK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- This deviceK134035 Transonic HCM 103 SystemTransonic Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| −1 | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| 0 (this device) | K134035 | Transonic HCM 103 System | Transonic Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 DXG? 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 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 |
|---|---|---|---|
| * | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorSummary page 4…poreal, Diagnostic monitor Proprietary Name: Transonic HCM103 System Predicate Devices: K082308: MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY… | 2008 |
| * | K010049 | Pulseco Hemodynamic Monitor CM71Summary page 4…L PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; EDWARDS LIFESCIENCES, LLC K010049: PULSECO HEMODYNAMIC MONITOR CM71, LiDCO Ltd. [K023960: LIDCOPLUS… | 2001 |
| † | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70 | 2003 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K082308.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this stand-alone system, cardiac output…
Read the full statement (101 words)
The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K134035: Transonic HCM 103 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K134035
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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