510(k) Report

FDA applicant

Shenzhen Delica Medical Equipment Co., Ltd.

Shenzhen, CN3 decisions2018–20220 recalls

FDA records 3 decisions for Shenzhen Delica Medical Equipment Co., Ltd. (Shenzhen, CN) from 2018 to 2022: 3 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Shenzhen Delica Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12019: 12022: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Delica Medical Equipment Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 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.

  • K173801Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 20182cite it

What has FDA decided for it lately?

  • K213009Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2022
  • K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2019
  • K173801Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd. · 2018

All 3 as Shenzhen Delica Medical Equipment Co., Ltd. →