510(k) · Cleared
ClearedThermodilution Cardiac Output Computer-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Edwards Laboratories · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jun 15, 1983 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 15, 1983
- Review
- 86 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK830892 Thermodilution Cardiac Output Computer-American Edwards Laboratories · 1983
- Descendant · cites it directly · 4 of its ownK051907 InnocorInnovision A/S · 2006
- Descendant · 2 generations on · 3 of its ownK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- Descendant · 2 generations on · 2 of its ownK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- Descendant · 2 generations on · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
- Descendant · 2 generations on · 0 of its ownK102047 Lci Option for InnocorInnovision A/S · 2011 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K051907InnocorInnovision A/S · 2006 · cites it directly4descendants
- K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007 · 2 generations on3descendants
- K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S · 2009 · 2 generations on2descendants
- K190561NICU V'02Cosmed Nordic Aps · 2020 · 2 generations on0descendants
- K102047Lci Option for InnocorInnovision A/S · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830892 | Thermodilution Cardiac Output Computer- | American Edwards Laboratories | 1983 | — |
| +1 | K051907 | Innocor | Innovision A/S | 2006 | — |
| +2 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| +2 | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including… | Innovision A/S | 2009 | — |
| +2 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
| +2 | K102047 | Lci Option for Innocor | Innovision A/S | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051907 | Innocor | 2006 | 4 |
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?
- Of its descendants, K051907 (Innovision A/S, 2006) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K830892 · printed Nov 3, 2026
Cite this page
510(k) Report. “K830892: Thermodilution Cardiac Output Computer-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830892
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026