510(k) Report

FDA applicant

Shenzhen Boon Medical Supply Co., Ltd.

Shenzhen, CN3 decisions2020–20240 recalls

FDA records 3 decisions for Shenzhen Boon Medical Supply Co., Ltd. (Shenzhen, CN) from 2020 to 2024: 3 510(k) clearances. All are in product code DXT (Injector And Syringe, Angiographic). 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, cardiovascular panel, where it files most

How often FDA has decided Shenzhen Boon Medical Supply Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12021: 12024: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Shenzhen Boon Medical Supply Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Boon Medical Supply 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?

  • DXTInjector And Syringe, Angiographic3decisions

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 4 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.

  • K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 20212cite it
  • K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 20202cite it

What has FDA decided for it lately?

  • K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd. · 2024
  • K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021
  • K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020

All 3 as Shenzhen Boon Medical Supply Co., Ltd. →