510(k) · Cleared
ClearedLidco Cnap Module
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 Aug 28, 2013 after a 135-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 28, 2013
- Review
- 135 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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. 2013, 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 LiDCO CNAP Module Is Indicated for the continuous, non-Invasive monitoring of arterial blood pressure In adults and pediatric patients from the age of 4 years by medical professionals. The LiDCO CNAP Module Is intended to be used with, and display on, the LiDCOrapid V2 Monitor. The LiDCO CNAP Module supports the following parameters: Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial…
Read the full statement (111 words)
The LiDCO CNAP Module Is Indicated for the continuous, non-Invasive monitoring of arterial blood pressure In adults and pediatric patients from the age of 4 years by medical professionals.
The LiDCO CNAP Module Is intended to be used with, and display on, the LiDCOrapid V2 Monitor.
The LiDCO CNAP Module supports the following parameters:
Continuous and oscillometric arterial blood pressure
Arterial systolic pressure
Arterial diastolic pressure
Arterial mean pressure
Heart rate
Locations 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131048: Lidco Cnap Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131048
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026