510(k) · Cleared

Cleared

Transonic Elsa System

K134051510(k) TraditionalCleared Jan 29, 2015394-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 Jan 29, 2015 as substantially equivalent to K960817 (Transonic Systems, Inc., 1997) and 1 other predicate after a 394-day review. Its family tree reaches back 4 generations to 1997.

Decided: Jan 29, 2015
Review: 394 days
Class: Class II
Product code: DXG
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K960817 (1997). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
3 generations backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
2 generations backK080116 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · Recalled
1 generation backK113821 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
This deviceK134051 Transonic Elsa SystemTransonic Systems, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K960817	HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)	Transonic Systems, Inc.	1997	1
−3	K980906	Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO	Transonic Systems, Inc.	1998	—
−2	K080116	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2008	1
−1	K113821	Transonic Costatus Cardiac Output System	Transonic Systems, Inc.	2012	—
0 (this device)	K134051	Transonic Elsa System	Transonic Systems, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K134051, 1997–2015Source: 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
*	K960817	HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) Summary page 4 …oreal, Diagnostic monitor Proprietary Name: Transonic ELSA System Predicate Devices: K960817: HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR K113821: TRANSON…	Transonic Systems, Inc.	1997	1
*	K113821	Transonic Costatus Cardiac Output System Summary page 4 …ELSA System Predicate Devices: K960817: HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR K113821: TRANSONIC COstatus Cardiac Output System Device Description: In accordance with section 510…	Transonic Systems, Inc.	2012	—

Also cleared against K960817: 3 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?

The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
2 of the 5 ancestors have a recall of any class.
3 other devices also cite its predicate K960817.

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. 2015, 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?

The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation; Oxygenator Blood Volume and other associated hemodynamic parameters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K134051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K134051: Transonic Elsa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134051

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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