510(k) · Cleared
Recalled · Class II · 2012Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 3, 2004 as substantially equivalent to K011000 (General Electric Medical Systems Information Techn, 2001) after a 37-day review. Its family tree reaches back 1 generation to 2001. 1 of the 54 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2004
- Review
- 37 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011000 (2001). 52 later devices descend from it, 2 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK011000 Tram 2001 ModuleGeneral Electric Medical Systems Information Techn · 2001 · Recalled
- This deviceK042642 Aware Transport Monitor System (Includes Aware Pod and Aware…Ge Medical Systems Information Technologies · 2004
- Descendant · cites it directly · 51 of its ownK071073 Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · 2 generations on · 38 of its ownK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- Descendant · 3 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 4 generations on · 14 of its ownK132533 Carescape Monitor B450GE Healthcare Finland Oy · 2013 · Recalled
- Descendant · 4 generations on · 13 of its ownK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B405 generations on · 2014
Most influential descendants
Showing 5 of 52 · See all- K071073Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies · 2007 · cites it directly51descendants
- K092027Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · 2 generations on38descendants
- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 3 generations on32descendants
- K132533Carescape Monitor B450GE Healthcare Finland Oy · 2013 · 4 generations on14descendants
- K131223Carescape Monitor B650GE Healthcare Finland Oy · 2013 · 4 generations on13descendants
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) | K042642 | Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor) | Ge Medical Systems Information Technologies | 2004 | — |
| +1 | K071073 | Solar 8000 and Transport Pro with Patient Data Module | Ge Medical Systems Information Technologies | 2007 | 13 |
| +2 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| +3 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +4 | K132533 | Carescape Monitor B450 | GE Healthcare Finland Oy | 2013 | 3 |
| +4 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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.
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
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…parameter Module) Classification Names: Physiological Patient Monitor Predicate Devices: K01 1000 TRAM 2001 Module escipton:The Aware Tm Transport Monitor System is a complete, high-acuity Dev… | 2001 |
What descends from it? (52)
See all 522 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2012 | Class II | Z-2015-2012 | Nonconforming Material/Component | GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of… |
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 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Aware TM Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED)…
Read the full statement (259 words)
The Aware TM Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.
The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.
The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042642: Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042642
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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