510(k) Report

FDA applicant

QT Medical, Inc.

Diamond Bar, CA5 decisions2018–20260 recalls

FDA records 5 decisions for QT Medical, Inc. (Diamond Bar, CA) from 2018 to 2026: 5 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DSA (Cable, Transducer And Electrode, Patient…). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 211 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided QT Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12021: 12022: 12023: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — QT Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like QT Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone3decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • DPSElectrocardiograph1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 219 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 211 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180157QT ECGQT Medical, Inc. · 20181cites it
  • K220795QT ECGQT Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K233521QT Ecg (QTERD100)QT Medical, Inc. · 2023
  • K220795QT ECGQT Medical, Inc. · 2022
  • K200722PCA-C1 series Patient CableQT Medical, Inc. · 2021
  • K180157QT ECGQT Medical, Inc. · 2018

All 5 as QT Medical, Inc. →