510(k) · Cleared

Recalled · Class II · 2019

Apexpro FH Telemetry System

K033365510(k) SpecialCleared Nov 6, 200316-day reviewClass II21 CFR 870.1025Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Nov 6, 2003 as substantially equivalent to K032369 (Ge Medical Systems Information Technologies, 2003) after a 16-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it. It has been recalled 3 times.

Decided: Nov 6, 2003
Review: 16 days
Class: Class II
Product code: MHX
Recalls: 3
Predicates: 1

Its longest line of descent runs back 3 generations to K000779 (2000). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK000779 Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2000 · Recalled
2 generations backK021325 Modification of Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
1 generation backK032369 Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
This deviceK033365 Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003
Descendant · cites it directly · 1 of its ownK080251 Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · Recalled
Descendant · 2 generations on · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K080251Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · cites it directly1descendant
K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000779	Apexpro Telemetry System	General Electric Medical Systems Information Techn	2000	2
−2	K021325	Modification of Apexpro Telemetry System	General Electric Medical Systems Information Techn	2002	2
−1	K032369	Modification to: Apexpro Telemetry System	Ge Medical Systems Information Technologies	2003	4
0 (this device)	K033365	Apexpro FH Telemetry System	Ge Medical Systems Information Technologies	2003	—
+1	K080251	Apexpro Telemetry Systems	Ge Medical Systems Information Technologies	2008	4
+2	K160685	Surveyor S4 Mobile Monitor	Mortara Instrument, Inc.	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2016	1	0

FIG. 1 — Lineage of K033365, 2000–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K032369	Modification to: Apexpro Telemetry System	Ge Medical Systems Information Technologies	2003	4

Also cleared against K032369: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080251	Apexpro Telemetry Systems	Ge Medical Systems Information Technologies	2008	1

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.
Jun 23, 2006	Not classified	Z-0054-2007	Other	System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
3 of the 3 ancestors have a recall of any class.
Of its descendants, K080251 (Ge Medical Systems Information Technologies, 2008) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K032369.

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	—

What is it indicated for?

The ApexPro FH 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 FH Telemetry System is intended to be installed in the hospital or…

Read the full statement (163 words)

The ApexPro FH 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 FH 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 Sp02. The ApexPro FH Telemetry System is intended to provide ECG data via

Ethernet to the computer platform for processing. The ApexPro FH 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/K033365 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033365: Apexpro FH Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033365

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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