510(k) · Cleared
Recalled · Class II · 2013Transonic 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 8, 2008 as substantially equivalent to K023960 (Lidco, Ltd., 2003) and 1 other predicate after a 236-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2008
- Review
- 236 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960817 (1997). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960817 HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)Transonic Systems, Inc. · 1997 · Recalled
- 1 generation backK980906 Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COTransonic Systems, Inc. · 1998
- This deviceK080116 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK113821 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK134051 Transonic Elsa SystemTransonic Systems, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960817 | HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) | Transonic Systems, Inc. | 1997 | 1 |
| −1 | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO | Transonic Systems, Inc. | 1998 | — |
| 0 (this device) | K080116 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2008 | — |
| +1 | K113821 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 11.2 · 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 |
|---|---|---|---|
| * | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70Summary page 1…Devices Panel Class II,74 DXG 21 CFR §870.1435 SUBSTANTIAL EQUIVALENCE' TO: K023960 LiD COplus HemodynamicLiC Lmte… | 2003 |
| * | K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COSummary page 1…LiD COplus HemodynamicLiC Lmte Monitor K980906 Transonic Hemodialysis Transonic Systems Inc.… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113821 | Transonic Costatus Cardiac Output System | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1147-2013 | Component design/selection | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 9.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113821 (Transonic Systems, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K023960.
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. 2008, 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 greater than or equal to 2 years old (child, adolescent, adult) 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/K080116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080116: Transonic Costatus Cardiac Output System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080116
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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