510(k) · Cleared

Recalled · Class II · 2013

Tram 2001 Module

K011000510(k) TraditionalCleared Jun 29, 200187-day reviewClass II21 CFR 870.1025Recalls 1

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 Jun 29, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 55 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it. It has been recalled once.

Decided: Jun 29, 2001
Review: 87 days
Class: Class II
Product code: MHX
Recalls: 1
Predicates: 0

54 later devices descend from it, 2 citing it directly. 1 of the 55 devices in this family, counting this one, has a Class I recall.

This deviceK011000 Tram 2001 ModuleGeneral Electric Medical Systems Information Techn · 2001
Descendant · cites it directly · 52 of its ownK042642 Aware Transport Monitor System (Includes Aware Pod and Aware…Ge Medical Systems Information Technologies · 2004 · Recalled
Descendant · 2 generations on · 51 of its ownK071073 Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · Recalled
Descendant · 3 generations on · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
Descendant · 4 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
Descendant · 5 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2004high 7 (2022) · low 0 (2005)2026

Class I recalls in this family

K133576 Monitor B406 generations on · 2014

Most influential descendants

Showing 5 of 54 · See all

K042642Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)Ge Medical Systems Information Technologies · 2004 · cites it directly52descendants
K071073Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · 2 generations on51descendants
K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · 3 generations on38descendants
K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 4 generations on32descendants
K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011000	Tram 2001 Module	General Electric Medical Systems Information Techn	2001	—
+1	K042642	Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)	Ge Medical Systems Information Technologies	2004	1
+2	K071073	Solar 8000 and Transport Pro with Patient Data Module	Ge Medical Systems Information Technologies	2007	13
+3	K092027	Carescape Monitor B850	Ge Medical Systems Information Technologies	2009	9
+4	K102239	Carescape Monitor B650	GE Healthcare Finland Oy	2010	8
+5	K132533	Carescape Monitor B450	GE Healthcare Finland Oy	2013	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	1	0
2009	2	0
2010	1	0
2012	1	0
2013	5	0
2014	3	1
2015	3	0
2016	3	0
2017	3	0
2019	3	0
2020	5	0
2021	1	0
2022	7	0
2023	4	0
2024	2	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K011000, 2001–2026Source: 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.

1 device in this family has a Class I recall. 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? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K042642	Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)	Ge Medical Systems Information Technologies	2004	52
K053121	Tram Module	GE Healthcare	2006	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 5, 2013	Class II	Z-0808-2014	Pending	Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K042642 (Ge Medical Systems Information Technologies, 2004) has gone furthest, with 52 descendants 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/K011000 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011000: Tram 2001 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011000

Report an extraction error

Are you the manufacturer?

Record history

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