510(k) · Cleared

Cleared

Model 9500 MR-Compatible Multigas Monitor

K954120510(k) TraditionalCleared Apr 2, 1997579-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

Magnetic Resonance Equipment Corp. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Apr 2, 1997 after a 579-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 59 later devices descend from it.

Decided: Apr 2, 1997
Review: 579 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 0

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

This deviceK954120 Model 9500 MR-Compatible Multigas MonitorMagnetic Resonance Equipment Corp. · 1997
Descendant · cites it directly · 57 of its ownK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
Descendant · 2 generations on · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
Descendant · 3 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
Descendant · 3 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
Descendant · 4 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

1998high 6 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 59 · See all

K023195Maglife C/Maglife C PlusSchiller Medical S.A. · 2003 · cites it directly57descendants
K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · 2 generations on56descendants
K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 3 generations on55descendants
K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 3 generations on53descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 4 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954120	Model 9500 MR-Compatible Multigas Monitor	Magnetic Resonance Equipment Corp.	1997	—
+1	K023195	Maglife C/Maglife C Plus	Schiller Medical S.A.	2003	—
+2	K040915	Magnitude 3150M Mri Patient Monitor, Model 3150M	Invivo Research, Inc.	2004	—
+3	K050399	Mri Compatible Patient Monitoring System, Model 3160	Invivo Research, Inc.	2005	—
+3	K053462	3160 Mri Patient Monitoring System	Invivo Corporation	2006	2
+4	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2009	1	0
2011	2	0
2012	2	0
2013	3	0
2014	3	0
2015	4	0
2016	3	0
2017	6	0
2018	1	0
2019	4	0
2020	4	0
2021	5	0
2022	3	0
2023	6	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K954120, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (59)

See all 59

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023195	Maglife C/Maglife C Plus	Schiller Medical S.A.	2003	57
K972535	Maglife C	Odam	1998	0

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, K023195 (Schiller Medical S.A., 2003) has gone furthest, with 57 descendants of its own.

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	—

https://510kreport.com/device/K954120 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954120: Model 9500 MR-Compatible Multigas Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954120

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026