510(k) · Cleared

Cleared

Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711

K021874510(k) TraditionalCleared Jul 12, 200235-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

Abbott Laboratories · DXG Computer, Diagnostic, Pre-Programmed, Single-Function

Cleared on Jul 12, 2002 as substantially equivalent to K853018 (Oximetrix, Inc., 1986) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.

Decided: Jul 12, 2002
Review: 35 days
Class: Class II
Product code: DXG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K853018 (1986). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK853018 Model 3000 Opticath ComputerOximetrix, Inc. · 1986 · Recalled
This deviceK021874 Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number…Abbott Laboratories · 2002
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
−1	K853018	Model 3000 Opticath Computer	Oximetrix, Inc.	1986	2
0 (this device)	K021874	Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711	Abbott Laboratories	2002	—
+1	K152006	Cogent Hemodynamic Monitoring System	Icu Medical, Inc.	2016	4
+2	K232048	Cogent™ Hemodynamic Monitoring System; Cogent™ HMS	Icu Medical	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K021874, 1986–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K853018	Model 3000 Opticath Computer Summary page 1 …List Number: 5671 1 I P r e d i c a t e Devices: Abbott Model 3000 Opticath Computer (SvOZ/TdCO), K853018 Abbott Continuous Cardiac Output System, renamed the Qvue, (CCO/TdCO), K932414 P r o p o s e d Device Description: The p…	Oximetrix, Inc.	1986	2
*	K932414	Continuous Cardiac Output System Summary page 1 …I P r e d i c a t e Devices: Abbott Model 3000 Opticath Computer (SvOZ/TdCO), K853018 Abbott Continuous Cardiac Output System, renamed the Qvue, (CCO/TdCO), K932414 P r o p o s e d Device Description: The proposed Abbott Q2TMPlus S02/Continuous Cardiac Output Computer is based on modi…	Abbott Laboratories	1994	4

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?

2 of the 2 ancestors have a recall of any class.
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.

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 Abbott Q2TMPlus S02/Continuous Cardiac Output Computer has the following indications for use:

It is intended for deriving and monitoring hemodynamic and cardiac parameters in patients with pre-existing central line access.

It monitors cardiac output, body core temperature and blood oxygen saturation. These and other calculated hemodynamic values are displayed and may be communicated to other external monitoring systems.

It is intended to be used in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021874: Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021874

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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