510(k) · Cleared

Cleared

Transonic HCM 102 System

K140017510(k) TraditionalCleared Sep 16, 2014257-day reviewClass II21 CFR 870.1435

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

Transonic Systems, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function

Cleared on Sep 16, 2014 as substantially equivalent to K060898 (Pulsion Medical Systems AG, 2006) and 1 other predicate after a 257-day review. Its family tree reaches back 1 generation to 2003.

Decided: Sep 16, 2014
Review: 257 days
Class: Class II
Product code: DXG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K023960 (2003). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK023960 Lidcoplus Hemodynamic Monitor System, Model HM 70Lidco, Ltd. · 2003
This deviceK140017 Transonic HCM 102 SystemTransonic Systems, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023960	Lidcoplus Hemodynamic Monitor System, Model HM 70	Lidco, Ltd.	2003	—
0 (this device)	K140017	Transonic HCM 102 System	Transonic Systems, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K140017, 2003–2014Source: 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 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

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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	Applicant	Decided	Recalls
*	K060898	Pulsion Picco Plus, Model 8100 Summary page 4 …poreal, Diagnostic monitor Proprietary Name: Transonic HCM102 System Predicate Devices: K060898: PULSION PICCO PLUS, MODEL 8100. K023960: LIDCOPLUS HEMODYNAMIC MONITOR…	Pulsion Medical Systems AG	2006	—
*	K023960	Lidcoplus Hemodynamic Monitor System, Model HM 70 Summary page 4 …Proprietary Name: Transonic HCM102 System Predicate Devices: K060898: PULSION PICCO PLUS, MODEL 8100. K023960: LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70. Device Description: In accordance with se…	Lidco, Ltd.	2003	—
†	K113821	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2012	—
†	K942377	Transtar Pressure Transducer	Medex, Inc.	1994	3

Also cleared against K060898: 2 other devices →

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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K060898.

How does its category compare?

All DXG devices

DXG 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

2007high 6 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXG

290in 2014

2007high 290 (2014) · low 104 (2011)2026

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

Recalls per year · DXG

2in 2020

2007high 6 (2009) · low 0 (2011)2026

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

Adverse event reports per year · DXG

8in 2025

2007high 83 (2018) · low 7 (2011)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?

Read the full statement (106 words)

The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient’s cardiac and volume status as well as 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 system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140017: Transonic HCM 102 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140017

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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