510(k) Report

FDA applicant

Shenzhen Coreray Technology, Ltd.

Shenzhen, CN4 decisions2018–20210 recalls

FDA records 4 decisions for Shenzhen Coreray Technology, Ltd. (Shenzhen, CN) from 2018 to 2021: 4 510(k) clearances. Most are in product codes DSA (Cable, Transducer And Electrode, Patient…) and DXQ (Blood Pressure Cuff). Since 2016 its 510(k)s took a median of 230 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Shenzhen Coreray Technology Co., Ltd.”.

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 Coreray Technology, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 22020: 12021: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Shenzhen Coreray Technology, 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?

  • DSACable, Transducer And Electrode, Patient, (Including Connector)2decisions
  • DXQBlood Pressure Cuff1decision
  • DQAOximeter1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 230 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K192404Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. · 20201cites it

What has FDA decided for it lately?

  • K211747Reusable NIBP CuffShenzhen Coreray Technology Co., Ltd. · 2021
  • K192404Patient Monitoring Cable (SpO2 Extension Cable)Shenzhen Coreray Technology, Ltd. · 2020
  • K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd. · 2018
  • K172797ECG Cable/LeadwiresShenzhen Coreray Technology, Ltd. · 2018

All 3 as Shenzhen Coreray Technology, Ltd. →The one decision as Shenzhen Coreray Technology Co., Ltd. →