510(k) Report

FDA applicant

Qisda Corporation

Taoyuan City, TW4 decisions2014–20190 recalls

FDA records 4 decisions for Qisda Corporation (Taoyuan City, TW) from 2014 to 2019: 4 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 102 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 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, radiology panel, where it files most

How often FDA has decided Qisda Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12017: 12018: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Qisda Corporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic3decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 102 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 79 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 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.

  • K181313BenQ Diagnostic Ultrasound SystemQisda Corporation · 20181cites it
  • K132690UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation · 20141cites it
  • K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation · 20171cites it

What has FDA decided for it lately?

  • K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2019
  • K181313BenQ Diagnostic Ultrasound SystemQisda Corporation · 2018
  • K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2017
  • K132690UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation · 2014

All 4 as Qisda Corporation →