510(k) Report

FDA applicant

Grandway Technology (Shenzhen) Limited

Shenzhen, CN21 decisions2011–20190 recalls

FDA records 21 decisions for Grandway Technology (Shenzhen) Limited (Shenzhen, CN) from 2011 to 2019: 21 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 162 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 16 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 Grandway Technology (Shenzhen) Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2011: 12013: 42014: 42015: 72017: 32018: 12019: 1
2011high 7 (2015) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Grandway Technology (Shenzhen) Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive21decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 162 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 184 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 16 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133619Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 20144cite it
  • K142088Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 20142cite it
  • K143735Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 20152cite it
  • K120675Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 20132cite it
  • K133618Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 20142cite it
  • K163679Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 20171cites it

What has FDA decided for it lately?

  • K191593Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited · 2019
  • K171379Digital Automatic Wrist Blood Pressure Monitor MD4300Grandway Technology (Shenzhen) Limited · 2018
  • K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 SeriesGrandway Technology (Shenzhen) Limited · 2017
  • K163679Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017
  • K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2017
  • K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 SeriesGrandway Technology (Shenzhen) Limited · 2015
  • K151583Digital Automatic Wrist Blood Pressure Monitor MD3900Grandway Technology (Shenzhen) Limited · 2015
  • K151587Digital Automatic Wrist Blood Pressure Monitor MD3200Grandway Technology (Shenzhen) Limited · 2015

All 21 as Grandway Technology (Shenzhen) Limited →