510(k) · Cleared
Recalled · Class II · 2019Modification of Apexpro Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 7, 2002 as substantially equivalent to K000779 (General Electric Medical Systems Information Techn, 2000) after an 11-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- May 7, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000779 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000779 Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- This deviceK021325 Modification of Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 3 of its ownK032369 Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK033365 Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK080251 Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K032369Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · cites it directly3descendants
- K033365Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003 · 2 generations on2descendants
- K080251Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · 2 generations on1descendant
- K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000779 | Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2000 | 2 |
| 0 (this device) | K021325 | Modification of Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | K032369 | Modification to: Apexpro Telemetry System | Ge Medical Systems Information Technologies | 2003 | 4 |
| +2 | K033365 | Apexpro FH Telemetry System | Ge Medical Systems Information Technologies | 2003 | 3 |
| +2 | K080251 | Apexpro Telemetry Systems | Ge Medical Systems Information Technologies | 2008 | 4 |
| +3 | K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 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.
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 |
|---|---|---|---|
| * | K000779 | Apexpro Telemetry SystemSummary page 1…Classification Names: 21 CFR 870.1025 Detector and Alarm, Arrhythmia 21 CFR 870.2910 Transmitters & Receivers, Physiological Signal, Radio Frequency Predicate Device: K000779 ApexPro Telemetry System Device Description: The ApexPro Telemetry System is composed of six major components: e The patient wor… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032369 | Modification to: Apexpro Telemetry System | 2003 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2019 | Class II | Z-0725-2020 | Software in the Use Environment | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information… |
| Aug 30, 2019 | Class II | Z-0175-2020 | Software design | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions. |
No ancestor or descendant has a 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 ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or…
Read the full statement (157 words)
The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
The physiological parameters monitored include ECG, non-invasive blood pressure and SpO.. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021325: Modification of Apexpro Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021325
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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