510(k) · Cleared
Recalled · 2009Q-Tel RMS (Rehabilitation Management System), Model 000503
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 25, 2001 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 25, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK003576 Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK041607 Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK050778 Telerehad 2004Scottcare · 2005
- Descendant · 3 generations on · 1 of its ownK212883 ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
- Descendant · 4 generations on · 0 of its ownK250259 TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK173969 Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A. · 2018
Most influential descendants
Showing 5 of 5 · See all- K041607Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004 · cites it directly4descendants
- K050778Telerehad 2004Scottcare · 2005 · 2 generations on2descendants
- K212883ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022 · 3 generations on1descendant
- K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025 · 4 generations on0descendants
- K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503 | Quinton, Inc. | 2001 | — |
| +1 | K041607 | Quinton Q-TE; RMS | Quinton Cardiology, Inc. | 2004 | 1 |
| +2 | K050778 | Telerehad 2004 | Scottcare | 2005 | — |
| +3 | K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 | — |
| +4 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025 | — |
| +2 | K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041607 | Quinton Q-TE; RMS | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2009 | Not classified | Z-1757-2010 | Other | 28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041607 (Quinton Cardiology, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K003576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003576: Q-Tel RMS (Rehabilitation Management System), Model 000503.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003576
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026