510(k) · Cleared
ClearedQCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QT Medical, Inc. · DPS Electrocardiograph
Cleared on Sep 29, 2026 as substantially equivalent to K120865 (Mortara Instrument, Inc., 2012) after a 245-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 29, 2026
- Review
- 245 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933143 (1994). 10 ancestors in all, the oldest K920626 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 4 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 3 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 2 generations backK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
- 1 generation backK120865 Rscribe ElectrocardiographMortara Instrument, Inc. · 2012 · Recalled
- This deviceK260250 QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph…QT Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −4 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −3 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −2 | K093339 | Eli PC Electrocardiograph | Mortara Instrument, Inc. | 2010 | 1 |
| −1 | K120865 | Rscribe Electrocardiograph | Mortara Instrument, Inc. | 2012 | 1 |
| 0 (this device) | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K120865 | Rscribe ElectrocardiographSummary page 5…RANSDUCER AND ELECTRODE, PAj I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K120865 RScribe Electrocardiograph DPS Device Description Summary 21 CFR 807.92(a)(4) # Purpose and Use: Non-invasive, prescription 12-… | 2012 |
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 32 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K120865.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 QCA 10/10W ECG System is a non-invasive prescription medical device intended for use by trained healthcare professionals in clinical settings (e.g., hospitals, medical clinics, physician offices). The device is intended to acquire, record, display, analyze, store, and print 12-lead ECG signals from both adult and pediatric patients (pediatric: >1 month to 21 years of age). The analysis function provides basic automated ECG measurements.
The device is not intended for use as a vital signs physiological monitor.
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/K260250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260250: QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260250
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026