510(k) · Cleared
Recalled · Class II · 2026Apexpro Telemetry Systems
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 Jun 20, 2008 as substantially equivalent to K032369 (Ge Medical Systems Information Technologies, 2003) and 2 other predicates after a 141-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jun 20, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000779 (2000). 8 ancestors in all, the oldest K891104 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000779 Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 3 generations backK021325 Modification of Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 2 generations backK032369 Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
- 1 generation backK033365 Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
- This deviceK080251 Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008
- Descendant · cites it directly · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000779 | Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2000 | 2 |
| −3 | K021325 | Modification of Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2002 | 2 |
| −2 | K032369 | Modification to: Apexpro Telemetry System | Ge Medical Systems Information Technologies | 2003 | 4 |
| −1 | K033365 | Apexpro FH Telemetry System | Ge Medical Systems Information Technologies | 2003 | 3 |
| 0 (this device) | K080251 | Apexpro Telemetry Systems | Ge Medical Systems Information Technologies | 2008 | — |
| +1 | K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K032369 | Modification to: Apexpro Telemetry SystemSummary page 1…21 CFR 870.1025 Physiological Patient Monitor (with arrhythmia detection or alarms Predicate Devices: K032369 ApexPro Telemetry System K033365 ApexPro FH Telemetry System K980299 Apex OXI… | 2003 |
| * | K033365 | Apexpro FH Telemetry SystemSummary page 1…ith arrhythmia detection or alarms Predicate Devices: K032369 ApexPro Telemetry System K033365 ApexPro FH Telemetry System K980299 Apex OXIMETER Device Description: The… | 2003 |
| * | K980299 | Apex OximeterSummary page 1…Predicate Devices: K032369 ApexPro Telemetry System K033365 ApexPro FH Telemetry System K980299 Apex OXIMETER Device Description: The ApexPro Telemetry System provides clinicians with patient… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160685 | Surveyor S4 Mobile Monitor | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2026 | Class II | Z-2242-2026 | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the… |
| 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. |
| Jan 28, 2011 | Not classified | Z-1522-2011 | Software design | GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K160685 (Mortara Instrument, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032369.
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. 2008, this device’s year, is highlighted.
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 (161 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, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro Telemetry System is also intended to provide physiologic data over the Unity Network to clinical information systems for display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080251 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080251: Apexpro Telemetry Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080251
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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