510(k) · Cleared
Recalled · Class II · 2020LiDCOunity v2 Hemodynamic Monitor
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 Jun 5, 2017 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 5, 2017
- Review
- 189 days
- Class
- Class II
- Product code
- DXG
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK163334 LiDCOunity v2 Hemodynamic MonitorLidco, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK253417 Masimo Root Monitoring SystemMasimo Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K253417Masimo Root Monitoring SystemMasimo Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | 2017 | — |
| +1 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K253417 | Masimo Root Monitoring System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2020 | Class II | Z-0756-2021 | Labeling mix-ups | The expiration date on labeling is incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K253417 (Masimo Corporation, 2026) 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. 2017, 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 LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for: 1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. 2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use…
Read the full statement (265 words)
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/881bs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index
Location of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma/Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163334: LiDCOunity v2 Hemodynamic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163334
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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