510(k) · Cleared
ClearedX-Scribe II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DPS Electrocardiograph
Cleared on Sep 6, 2002 as substantially equivalent to K900720 (Mortara Instrument, Inc., 1990) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Sep 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900720 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900720 Mortara Instrument Model X-Scribe (Treadmill Included)Mortara Instrument, Inc. · 1990
- This deviceK022618 X-Scribe IIMortara Instrument, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK152944 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise…Mortara Instrument, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK092663 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2009 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900720 | Mortara Instrument Model X-Scribe (Treadmill Included) | Mortara Instrument, Inc. | 1990 | — |
| 0 (this device) | K022618 | X-Scribe II | Mortara Instrument, Inc. | 2002 | — |
| +1 | K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing… | Mortara Instrument, Inc. | 2016 | 5 |
| +1 | K092663 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K900720 | Mortara Instrument Model X-Scribe (Treadmill Included)Summary page 1…rocardiograph (Class II Per 21 CFR fj870.2340) Legally marketed devices to which S.E. is claimed Mortara X-Scribe Stress Exercise System - 510(k) K900720 Quinton Q-Stress - 510(k) K 001492 Description: The Mortara X-Scribe II is the latest evolution of the M… | 1990 |
| * | K001492 | Quinton Q-Stress, Model 000483Summary page 1…arketed devices to which S.E. is claimed Mortara X-Scribe Stress Exercise System - 510(k) K900720 Quinton Q-Stress - 510(k) K 001492 Description: The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic too… | 2000 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K152944 (Mortara Instrument, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 device is indicated for use to acquire, process, record, archive, analyze, and output electrocardiographic data obtained during physiologic stress exercise testing.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The device is indicated for use on adult populations, typically symptomatic.
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/K022618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022618: X-Scribe II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022618
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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