510(k) · Cleared
Recalled · Class II · 2013Tram Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 5, 2006 as substantially equivalent to K011000 (General Electric Medical Systems Information Techn, 2001) after a 149-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 2 times.
- Decided
- Apr 5, 2006
- Review
- 149 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011000 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011000 Tram 2001 ModuleGeneral Electric Medical Systems Information Techn · 2001 · Recalled
- This deviceK053121 Tram ModuleGE Healthcare · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011000 | Tram 2001 Module | General Electric Medical Systems Information Techn | 2001 | 1 |
| 0 (this device) | K053121 | Tram Module | GE Healthcare | 2006 | — |
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 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
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 | Decided |
|---|---|---|---|
| * | K011000 | Tram 2001 ModuleSummary page 1…diotachomcter & rate alarm) 21 C FR 870.2700 Oxi mCtCr, PLulse Predicate Devices: K01 1000 GEMS-IT Transport Rcmote ACquisition Module (TI,. ANM')… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 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. |
| Apr 3, 2013 | Class II | Z-2117-2013 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K011000.
How does its category compare?
All MHX devicesMHX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 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 | — |
What is it indicated for?
The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside…
Read the full statement (173 words)
The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system.
Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM Module acquires, processes and stores information regarding these parameters.
The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The dcvice is intended for use as part of a transport monitoring system for intra-hospital triasport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053121 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053121: Tram Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053121
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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