510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories

K052976510(k) SpecialCleared Jan 13, 200681-day reviewClass II21 CFR 870.1425

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

GE Healthcare · DQK Computer, Diagnostic, Programmable

Cleared on Jan 13, 2006 as substantially equivalent to K922876 (Datex Division Instrumentarium Corp., 1993) after an 81-day review. Its family tree reaches back 1 generation to 1993.

Decided: Jan 13, 2006
Review: 81 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922876 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK922876 AS/3 Cop ModuleDatex Division Instrumentarium Corp. · 1993
This deviceK052976 Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and AccessoriesGE Healthcare · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922876	AS/3 Cop Module	Datex Division Instrumentarium Corp.	1993	—
0 (this device)	K052976	Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories	GE Healthcare	2006	—

FIG. 1 — Lineage of K052976, 1993–2006Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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? (1)

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
*	K922876	AS/3 Cop Module Summary page 1 …Ohmeda S/5 TM Cardiac Output module, E-COP is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876). Page 2 of 3…	Datex Division Instrumentarium Corp.	1993	—

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?

Its one ancestor has no recall.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The Datex-Ohmeda S/5 TM Cardiac Output module, E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.

The device is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052976: Datex-Ohmeda S/5 Cardiac Output Module, E-Cop and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052976

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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