510(k) · Cleared
Cleareders2 - ergoline Rehabilitation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ergoline GmbH · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 15, 2022 as substantially equivalent to K050778 (Scottcare, 2005) after a 308-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jul 15, 2022
- Review
- 308 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003576 (2001). 4 ancestors in all, the oldest K895719 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003576 Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 2001 · Recalled
- 2 generations backK041607 Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004 · Recalled
- 1 generation backK050778 Telerehad 2004Scottcare · 2005
- This deviceK212883 ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
- Descendant · cites it directly · 0 of its ownK250259 TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503 | Quinton, Inc. | 2001 | 1 |
| −2 | K041607 | Quinton Q-TE; RMS | Quinton Cardiology, Inc. | 2004 | 1 |
| −1 | K050778 | Telerehad 2004 | Scottcare | 2005 | — |
| 0 (this device) | K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 | — |
| +1 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K050778 | Telerehad 2004Summary page 4…ing Devices (21 CFR 870.2910, Product Code DRG) Predicate Device Predicate Device: TeleRehab 2004 Cardiopulmonary Rehabilitation System, K050778 Intended Use The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (front… | 2005 |
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 |
|---|---|---|---|
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K250259 (The ScottCare Corporation, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ers2 — ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal
plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate
calculation, displayed for visual QRS complex assessment and to control the training load for a patient’s rehabilitation or
preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc.
pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
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/K212883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212883: ers2 - ergoline Rehabilitation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212883
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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