510(k) · Cleared
Recalled · Class II · 2024Rscribe Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DPS Electrocardiograph
Cleared on Jul 19, 2012 as substantially equivalent to K093339 (Mortara Instrument, Inc., 2010) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 19, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933143 (1994). 9 ancestors in all, the oldest K920626 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 2 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 1 generation backK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
- This deviceK120865 Rscribe ElectrocardiographMortara Instrument, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK260250 QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph…QT Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK160746 CARDIOLINE touchECGCardioline S.P.A · 2016
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 |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −2 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −1 | K093339 | Eli PC Electrocardiograph | Mortara Instrument, Inc. | 2010 | 1 |
| 0 (this device) | K120865 | Rscribe Electrocardiograph | Mortara Instrument, Inc. | 2012 | — |
| +1 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026 | — |
| +1 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K093339 | Eli PC ElectrocardiographSummary page 1…ts RScribe Electrocardiograph is substantially equivalent to the legally marketed devices presently in distribution: *Mortara Instrument ELI PC Electrocardiograph (K093339). *Mortara Instrument ELI 230 Electrocardiograph (K1O0i127) Description: The proposed Mortara Instrument RScribe is an elec… | 2010 |
| * | K100127 | Eli 230 Electrocardiograph | 2010 |
| † | K082946 | Mortara Eli 350 Electrocardiograph | 2008 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2024 | Class II | Z-0322-2025 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K260250 (QT Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093339.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device. * The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * 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…
Read the full statement (166 words)
The proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device.
* The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
* The device is indicated for use to provide interpretation of the data for consideration by a physician.
* 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 interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
* The device is indicated for use on adult and pediatric populations.
* The device is not intended to be used as a vital signs physiological monitor.
* The device is not designed for out of hospital transport.
* The device is not designed for use in highly invasive environments, such as an operating theatre.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120865: Rscribe Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120865
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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