510(k) · Cleared

Cleared

GE Marquette Prism Information Server Applications

K001268510(k) TraditionalCleared Jul 17, 200088-day reviewClass II21 CFR 870.1025

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

General Electric Medical Systems Information Techn · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Jul 17, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Jul 17, 2000
Review: 88 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

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

This deviceK001268 GE Marquette Prism Information Server ApplicationsGeneral Electric Medical Systems Information Techn · 2000
Descendant · cites it directly · 1 of its ownK020661 Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002
Descendant · cites it directly · 0 of its ownK032582 Unity Network Patient Data ServerGe Medical Systems Information Technologies · 2003
Descendant · 2 generations on · 0 of its ownK032346 Unity Network IS Patient ViewerGe Medical Systems Information Technologies · 2003

Most influential descendants

Showing 3 of 3 · See all

K020661Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002 · cites it directly1descendant
K032582Unity Network Patient Data ServerGe Medical Systems Information Technologies · 2003 · cites it directly0descendants
K032346Unity Network IS Patient ViewerGe Medical Systems Information Technologies · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001268	GE Marquette Prism Information Server Applications	General Electric Medical Systems Information Techn	2000	—
+1	K020661	Unity IS Patient Viewer	General Electric Medical Systems Information Techn	2002	—
+1	K032582	Unity Network Patient Data Server	Ge Medical Systems Information Technologies	2003	—
+2	K032346	Unity Network IS Patient Viewer	Ge Medical Systems Information Technologies	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0

FIG. 1 — Lineage of K001268, 2000–2003Source: 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 MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K020661	Unity IS Patient Viewer	General Electric Medical Systems Information Techn	2002	1
K032582	Unity Network Patient Data Server	Ge Medical Systems Information Technologies	2003	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, K020661 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

https://510kreport.com/device/K001268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001268: GE Marquette Prism Information Server Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001268

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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