QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)— 510(k) K260250
Substantially EquivalentQT Medical, Inc.
FDA 510(k) clearance K260250 for QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W), Substantially Equivalent on 2026-09-29. Applicant: QT Medical, Inc.. Device class: 2.
Summary
QT Medical, Inc. cleared two electrocardiographs in this file: the QCA 10 (QCARD-10) and the QCA 10W (QCARD-10W). Both fall under DPS, electrocardiographs. The record doesn't say what the "W" variant changes.
Class II, 21 CFR 870.2340. The Cardiovascular panel reviewed it as a Traditional 510(k).
QT Medical filed from Diamond Bar, California. Review took 245 days (January 27 to September 29, 2026). The record doesn't explain the length of the clock.
Clearance details
- Applicant
- QT Medical, Inc.
- Product code
- Product code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Diamond Bar, CA, US
Recent devices under product code DPS
view allMore clearances from QT Medical, Inc.
view allAdverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.