510(k) · Cleared
Recalled · 2009Model 3000 Opticath Computer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oximetrix, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 13, 1986 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 13, 1986
- Review
- 180 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK853018 Model 3000 Opticath ComputerOximetrix, Inc. · 1986
- Descendant · cites it directly · 2 of its ownK021874 Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number…Abbott Laboratories · 2002
- Descendant · 2 generations on · 1 of its ownK152006 Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK232048 Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023
Most influential descendants
Showing 3 of 3 · See all- K021874Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711Abbott Laboratories · 2002 · cites it directly2descendants
- K152006Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016 · 2 generations on1descendant
- K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853018 | Model 3000 Opticath Computer | Oximetrix, Inc. | 1986 | — |
| +1 | K021874 | Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711 | Abbott Laboratories | 2002 | — |
| +2 | K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016 | 4 |
| +3 | K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 11.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021874 | Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711 | 2002 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2009 | Not classified | Z-0143-2010 | Component design/selection | Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Aug 11, 2009 | Not classified | Z-0144-2010 | Component design/selection | Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021874 (Abbott Laboratories, 2002) has gone furthest, with 2 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/K853018 · printed Nov 5, 2026
Cite this page
510(k) Report. “K853018: Model 3000 Opticath Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K853018
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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