510(k) · Cleared
Recalled · Class II · 2024Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DPS Electrocardiograph
Cleared on Jan 6, 2016 as substantially equivalent to K022618 (Mortara Instrument, Inc., 2002) after a 92-day review. Its family tree reaches back 2 generations to 1990. It has been recalled 5 times.
- Decided
- Jan 6, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900720 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK900720 Mortara Instrument Model X-Scribe (Treadmill Included)Mortara Instrument, Inc. · 1990
- 1 generation backK022618 X-Scribe IIMortara Instrument, Inc. · 2002
- This deviceK152944 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise…Mortara Instrument, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900720 | Mortara Instrument Model X-Scribe (Treadmill Included) | Mortara Instrument, Inc. | 1990 | — |
| −1 | K022618 | X-Scribe II | Mortara Instrument, Inc. | 2002 | — |
| 0 (this device) | K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing… | Mortara Instrument, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K022618 | X-Scribe IISummary page 5…Traditional 510(k) Notification 3. Predicate Device to which this is Substantially Equivalent XScribe II K022618 This predicate device has not been subject to a design-related recall 4. Device Description The XScribe / Q-Stress device… | 2002 |
| † | K142105 | Eli 380 Electrocardiograph | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2024 | Class II | Z-0321-2025 | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this… |
| Oct 11, 2024 | Class II | Z-0325-2025 | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this… |
| Dec 8, 2023 | Class II | Z-0705-2024 | Software design | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| Dec 8, 2023 | Class II | Z-0706-2024 | Software design | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| Mar 18, 2020 | Class II | Z-1817-2020 | 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?
- The line of descent spans 26 years and passes through 1 company; a new generation was cleared every 13.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K022618.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device may interface with equipment for pulmonary function testing and other devices…
Read the full statement (106 words)
The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician.
The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment.
The device is not intended to be used as a vital signs physiological monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152944 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152944: Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152944
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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