510(k) · Cleared
Recalled · Class II · 2020Quinton Q-TE; RMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton Cardiology, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 16, 2004 as substantially equivalent to K003576 (Quinton, Inc., 2001) after a 31-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 16, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003576 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003576 Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 2001 · Recalled
- This deviceK041607 Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK050778 Telerehad 2004Scottcare · 2005
- Descendant · 2 generations on · 1 of its ownK212883 ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK250259 TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
- Descendant · cites it directly · 0 of its ownK173969 Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A. · 2018
Most influential descendants
Showing 4 of 4 · See all- K050778Telerehad 2004Scottcare · 2005 · cites it directly2descendants
- K212883ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022 · 2 generations on1descendant
- K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025 · 3 generations on0descendants
- K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503 | Quinton, Inc. | 2001 | 1 |
| 0 (this device) | K041607 | Quinton Q-TE; RMS | Quinton Cardiology, Inc. | 2004 | — |
| +1 | K050778 | Telerehad 2004 | Scottcare | 2005 | — |
| +2 | K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 | — |
| +3 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025 | — |
| +1 | K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503Summary page 1…frequency physiological signal transmitter and receiver 10. The Q-Tel RMS is substantially equivalent to the Q-Tel RMS (K003576). 11. Description: The Q-Tel RMS telemetry system measures the electrical activity of a patient's heart during an exercise c… | 2001 |
| † | K974149 | Ambulatory X-12 Telemetry Module | 1998 |
| † | K000882 | Datex-Ohmeda CS/3 Telemetry System | 2000 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2020 | Class II | Z-1818-2020 | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K050778 (Scottcare, 2005) has gone furthest, with 2 descendants of its own.
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 device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation. Multiple central…
Read the full statement (171 words)
The device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation.
Multiple central receivers may be used and connected to a local area network.
Specified wireless data entry devices may be connected to the system via a wireless access point and be used as a station for entry of patient session data.
Optional workstation(s) may be connected to the system via a network for entering and viewing patient demographic and rehab session data. The workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms.
ECG analysis may include 12-lead EGG interpretation.
Patient demographics, exercise prescription, scheduling information, and collected data can be ported to an outcomes management program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041607: Quinton Q-TE; RMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041607
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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