510(k) · Cleared
ClearedLidco System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lidco, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 8, 1999 as substantially equivalent to K810352 (American Edwards Laboratories, 1981) and 1 other predicate after a 925-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Jan 8, 1999
- Review
- 925 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K760192 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK760192 Computer, Thermodilution Cardiac (9520)Edwards Laboratories · 1976
- This deviceK962918 Lidco SystemLidco, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760192 | Computer, Thermodilution Cardiac (9520) | Edwards Laboratories | 1976 | — |
| 0 (this device) | K962918 | Lidco System | Lidco, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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? (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 |
|---|---|---|---|
| * | K810352 | Swan-Ganz Flow-Directed ThermodilutionSummary page 2…ected Thermodilution Catheter CRITERIA LiDCo SYSTEM BAXTER / EDWARDS FEATURE MODEL 93B - 131 - 7F FEATURE 1. Registration Status Class 11 510(K) Applied for Granted # K810352 2. Intended Use & Target Population (i) Intended use:cardiac output Cardiac output determination determination & measurement of… | 1981 |
| * | K760192 | Computer, Thermodilution Cardiac (9520)Summary page 5…s Model 9520 Cardiac Output Computer CRITERIA LiDCo SYSTEM BAXTER / EDWARDS ' FEATURE MODEL 98520 FEATURE 1. Registration Status Class 11 510(k) Applied for Granted # K760192 2. Intended Use & Target Population (i) intended use:cardiac output Cardiac output determination determination & measurement of… | 1976 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K810352.
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 | — |
What is it indicated for?
Diagnostic aid (cardiac output determination). The LIDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962918: Lidco System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962918
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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