510(k) · Cleared
ClearedTransonic Costatus Cardiac Output 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 7, 2012 as substantially equivalent to K080116 (Transonic Systems, Inc., 2008) and 2 other predicates after a 255-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Sep 7, 2012
- Review
- 255 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960817 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 2 generations backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- 1 generation backK080116 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · Recalled
- This deviceK113821 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK134051 Transonic Elsa SystemTransonic Systems, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K134051Transonic Elsa SystemTransonic Systems, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −2 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| −1 | K080116 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2008 | 1 |
| 0 (this device) | K113821 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2012 | — |
| +1 | K134051 | Transonic Elsa System | Transonic Systems, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K080116 | Transonic Costatus Cardiac Output SystemSummary page 1…Hemodynamic monitor Proprietary Name: COstatus System for Infants Predicate Devices: K0801 16: Transonic COstatus cardiac output system (for use with 2 years and older patients)… | 2008 |
| * | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COSummary page 1…K0801 16: Transonic COstatus cardiac output system (for use with 2 years and older patients) K980906: Transonic hemodialysis monitor, Cardiac K023960: LIOCOPLUS hemodynamic monitor system Devic… | 1998 |
| * | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70Summary page 1…(for use with 2 years and older patients) K980906: Transonic hemodialysis monitor, Cardiac K023960: LIOCOPLUS hemodynamic monitor system Device Description: In accordance with section 510(k) for the Federal Food, Drug, and 'C… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K134051 | Transonic Elsa System | 2015 | 0 |
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 15 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K134051 (Transonic Systems, Inc., 2015) has gone furthest, with 0 descendants of its own.
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. 2012, 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 COstatus system is indicated for use in patients 1 month or older with
arterial and venous lines in the diagnostic assessment of cardiovascular status including
cardiac output and associated hemodynamic parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113821: Transonic Costatus Cardiac Output System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113821
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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