510(k) Report

FDA applicant

Mianyang Meike Electronic Equipment Co., Ltd.

Mianyang, CN3 decisions2013–20210 recalls

FDA records 3 decisions for Mianyang Meike Electronic Equipment Co., Ltd. (Mianyang, CN) from 2013 to 2021: 3 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, radiology panel, where it files most

How often FDA has decided Mianyang Meike Electronic Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2013: 12019: 12021: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Mianyang Meike Electronic Equipment Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 20132cite it
  • K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K210591Palm Bladder Scanner - PBSV7.1Mianyang Meike Electronic Equipment Co., Ltd. · 2021
  • K191307Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. · 2019
  • K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013

All 3 as Mianyang Meike Electronic Equipment Co., Ltd. →