510(k) Report

FDA applicant

Shenzhen Delicate Electronics Co., Ltd.

Shanghai, CN2 decisions2010–20130 recalls

FDA records 2 decisions for Shenzhen Delicate Electronics Co., Ltd. (Shanghai, CN) from 2010 to 2013: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and OQQ (Diagnostic Ultrasonic Transducer, Robotic). Its devices cite 2 predicates, 1 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 Shenzhen Delicate Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12013: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Shenzhen Delicate Electronics Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Delicate Electronics 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • OQQDiagnostic Ultrasonic Transducer, Robotic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K122710Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 20132cite it
  • K092164Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UAShenzhen Delicate Electronics Co., Ltd. · 20102cite it

What has FDA decided for it lately?

  • K122710Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
  • K092164Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UAShenzhen Delicate Electronics Co., Ltd. · 2010

All 2 as Shenzhen Delicate Electronics Co., Ltd. →