510(k) Report

FDA applicant

Ningbo Diaier Electronic Co., Ltd.

Yuyao City, Zhejiang, CN3 decisions2009–20130 recalls

FDA records 3 decisions for Ningbo Diaier Electronic Co., Ltd. (Yuyao City, Zhejiang, CN) from 2009 to 2013: 3 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 3 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 Ningbo Diaier Electronic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12010: 12013: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ningbo Diaier Electronic Co., Ltd. by year, 2009–2026Sources: 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-Invasive3decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd. · 20092cite it

What has FDA decided for it lately?

  • K123839WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd. · 2013
  • K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd. · 2010
  • K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd. · 2009

All 3 as Ningbo Diaier Electronic Co., Ltd. →