Data / Medical devices / United States / QT Medical, Inc
QT Medical, Inc: FDA-registered device maker in Diamond Bar, CA, United States, 5 510(k) clearances
QT Medical, Inc is registered with the FDA (registration 3013684844) in Diamond Bar, CA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013684844
- Address
- 1370 Valley Vista Drive, Suite 266, Diamond Bar, CA, United States, 91765
- Owner or operator
- QT MEDICAL, INC (10058094)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- July 15, 2018
- Registered through
- 2027
- Brand names listed
- ECG Recorder (PCA 300), PCA 500, PCA 500+, PCA-A100 QHeart Cable L, PCA-A110 QHeart Cable Z, PCA-A120 L QHeart Cable GL, PCA-A120 S QHeart Cable GS, PCA-A130 QHeart Cable P and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2026 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | DPS | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| December 6, 2023 | K233521 | QT ECG (QTERD100) | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| September 26, 2022 | K220795 | QT ECG | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| June 3, 2021 | K200722 | PCA-C1 series Patient Cable | DSA | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| May 4, 2018 | K180157 | QT ECG | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrode, Electrocardiograph
- All makers of Electrocardiograph
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Cable, Electrode
Updated September 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.