510(k) · Cleared
ClearedTeleRehab Aermos Cardiopulmonary Rehabilitation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The ScottCare Corporation · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 4, 2025 as substantially equivalent to K212883 (Ergoline GmbH, 2022) after a 127-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jun 4, 2025
- Review
- 127 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003576 (2001). 5 ancestors in all, the oldest K895719 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK003576 Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 2001 · Recalled
- 3 generations backK041607 Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004 · Recalled
- 2 generations backK050778 Telerehad 2004Scottcare · 2005
- 1 generation backK212883 ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
- This deviceK250259 TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503 | Quinton, Inc. | 2001 | 1 |
| −3 | K041607 | Quinton Q-TE; RMS | Quinton Cardiology, Inc. | 2004 | 1 |
| −2 | K050778 | Telerehad 2004 | Scottcare | 2005 | — |
| −1 | K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K212883 | ers2 - ergoline Rehabilitation SystemSummary page 5…R 870.2300 Review Panel Cardiovascular 3. Predicate Device ers2 - ergoline Rehabilitation System (“ers2”) - K212883 Reference Device iT20 Telemetry Transmitter - Edan Instruments, Inc. - K161056 1619692645.… | 2022 |
| † | K161056 | Telemetry Transmitter | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2025, 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 TeleRehab Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use…
Read the full statement (120 words)
The TeleRehab Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250259: TeleRehab Aermos Cardiopulmonary Rehabilitation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250259
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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