510(k) · Cleared

Cleared

Lidcorapid V2 Monitor

K122247510(k) TraditionalCleared Mar 20, 2013236-day reviewClass II21 CFR 870.1435

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lidco, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function

Cleared on Mar 20, 2013 after a 236-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Mar 20, 2013
Review: 236 days
Class: Class II
Product code: DXG
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK122247 Lidcorapid V2 MonitorLidco, Ltd. · 2013
Descendant · cites it directly · 1 of its ownK152006 Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016 · Recalled
Descendant · 2 generations on · 0 of its ownK232048 Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023

Most influential descendants

Showing 2 of 2 · See all

K152006Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016 · cites it directly1descendant
K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K122247	Lidcorapid V2 Monitor	Lidco, Ltd.	2013	—
+1	K152006	Cogent Hemodynamic Monitoring System	Icu Medical, Inc.	2016	4
+2	K232048	Cogent™ Hemodynamic Monitoring System; Cogent™ HMS	Icu Medical	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2023	1	0

FIG. 1 — Lineage of K122247, 2013–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152006	Cogent Hemodynamic Monitoring System	Icu Medical, Inc.	2016	1

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, K152006 (Icu Medical, Inc., 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DXG devices

DXG 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

2007high 6 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXG

290in 2014

2007high 290 (2014) · low 104 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXG

2in 2020

2007high 6 (2009) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXG

8in 2025

2007high 83 (2018) · low 7 (2011)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 LiDOarapid V2 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 mteasurerbentof blood pressure, cardiac output and associated. hemodyniaric parameters in adult patients.

2. When connected to the 815 Module: monitoringthe.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 guideahesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K122247 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122247: Lidcorapid V2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122247

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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