FDA applicant

Shenzhen Biocare Electronics Co., Ltd.

Shanghai, CN5 decisions2010–20130 recalls

FDA records 5 decisions for Shenzhen Biocare Electronics Co., Ltd. (Shanghai, CN) from 2010 to 2013: 5 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and KNG (Monitor, Ultrasonic, Fetal). Its devices cite 6 predicates, 4 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 Biocare Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010high 2 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

Planning a device like Shenzhen Biocare 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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Shenzhen Biocare Electronics Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?