510(k) · Cleared

Cleared

Rac 2A Module Housing

K973984510(k) TraditionalCleared Jan 16, 199888-day reviewClass II21 CFR 868.1400

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

Marquette Medical Systems, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Jan 16, 1998 as substantially equivalent to K960272 (Marquette Electronics, Inc., 1996) and 4 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1991.

Decided: Jan 16, 1998
Review: 88 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K904789 (1991). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK904789 Series 7000 Carbon Dioxide ModuleMarquette Electronics, Inc. · 1991
1 generation backK960272 Eagle 3000/3100 Patient MonitorMarquette Electronics, Inc. · 1996
This deviceK973984 Rac 2A Module HousingMarquette Medical Systems, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K904789	Series 7000 Carbon Dioxide Module	Marquette Electronics, Inc.	1991	—
−1	K960272	Eagle 3000/3100 Patient Monitor	Marquette Electronics, Inc.	1996	—
0 (this device)	K973984	Rac 2A Module Housing	Marquette Medical Systems, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	3	0
1996	2	0

FIG. 1 — Lineage of K973984, 1991–1998Source: 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 CCK? 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 CCK device

#1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K960272	Eagle 3000/3100 Patient Monitor Summary page 2 …nterfaces a module to a Marquette Eagle monitor, is substantially equivalent to devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This devi…	Marquette Electronics, Inc.	1996	—
*	K960418	Eagle Patient Monitor Summary page 2 …a module to a Marquette Eagle monitor, is substantially equivalent to devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This device is vie…	Marquette Electronics, Inc.	1996	—
*	K961139	Eagle Patient Monitor Model 3000/3100 Summary page 2 …to a Marquette Eagle monitor, is substantially equivalent to devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This device is viewed as a…	Marquette Electronics, Inc.	1996	—
Kept off the family tree	K200598	FDA’s K200598 is Voyant Maryland Fusion Device Our OCR of the scanned summary read K200598, which FDA decided on Apr 8, 2020, after this device was decided (Jan 16, 1998), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 2 …le monitor, is substantially equivalent to devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This device is viewed as a component of a syst…	Applied Medical Resources Corp.	2020	—
*	K943977	Smart Anesthesia Multi-Gas (Sam) Module Summary page 2 …ivalent to devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This device is viewed as a component of a system. The RAC 2A adds modularity t…	Marquette Electronics, Inc.	1995	—
*	K950581	Smart Anesthesia Multi-Gas (Sam) Module Summary page 2 …o devices already in legal commercial distribution: Eagle patient monitors: K960272, K960418, K961139; Tram-rac: K200598; Tram-rac / SAM module: K943977, K950581. 4, Device Description and Intended Use This device is viewed as a component of a system. The RAC 2A adds modularity to Marquet…	Marquette Electronics, Inc.	1995	—

Also cleared against K960272: 1 other device →

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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
None of the 8 ancestors has a recall.
1 other device also cites its predicate K960272.

How does its category compare?

All CCK devices

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCK

3in 2025

2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007high 592 (2024) · low 56 (2007)2026

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

Recalls per year · CCK

1in 2022

2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, 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	5	56	0	7
2008	3	248	1	20
2009	3	101	19	21
2010	3	125	4	12
2011	2	—	14	18
2012	7	150	3	13
2013	4	132	2 (1)	28
2014	9	166	0	51
2015	5	105	1	114
2016	2	—	0	88
2017	5	134	0	58
2018	6	296	5	63
2019	7	261	7 (7)	141
2020	4	188	1	2,302
2021	4	227	0	2,272
2022	3	226	1	2,475
2023	4	555	0	1,637
2024	3	592	0	1,216
2025	3	169	0	1,259
2026	3	224	0	—

What is it indicated for?

The RAC 2A adds modularity to the Marquette Eagle configured product line. it is used to house the module [SAM (Smart Anesthesia Multi-gas) module] and provides an interface to the Eagle display. The module's patient information may be displayed on the Marquette Eagle monitor.

This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973984 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973984: Rac 2A Module Housing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973984

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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