510(k) Report

FDA applicant

Shenzhen Kingyield Technology Co., Ltd.

Shenzhen, Guangdong, CN5 decisions2008–20180 recalls

FDA records 5 decisions for Shenzhen Kingyield Technology Co., Ltd. (Shenzhen, Guangdong, CN) from 2008 to 2018: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DQA (Oximeter). Its devices cite 4 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 Shenzhen Kingyield Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 12012: 12013: 12017: 12018: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Shenzhen Kingyield Technology Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Kingyield Technology Co., Ltd.’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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K083043King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd. · 20082cite it
  • K112042Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 20121cites it
  • K182018Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K182018Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2018
  • K161530Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2017
  • K123801Finger Pulse OximeterShenzhen Kingyield Technology Co., Ltd. · 2013
  • K112042Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 2012
  • K083043King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd. · 2008

All 5 as Shenzhen Kingyield Technology Co., Ltd. →