510(k) Report

FDA applicant

Beijing Demax Medical Technology Co.,Ltd

Beijing, CN4 decisions2015–20240 recalls

FDA records 4 decisions for Beijing Demax Medical Technology Co.,Ltd (Beijing, CN) from 2015 to 2024: 4 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and MAV (Syringe, Balloon Inflation). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 Beijing Demax Medical Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12023: 22024: 1
2015high 2 (2023) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Beijing Demax Medical Technology Co.,Ltd by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter2decisions
  • MAVSyringe, Balloon Inflation1decision
  • DXCClamp, Vascular1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 166 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 56 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 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.

  • K222182Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd · 20231cites it

What has FDA decided for it lately?

  • K242248Introducer Sheath KitsBeijing Demax Medical Technology Co.,Ltd · 2024
  • K222184Introducer Sheath KitsBeijing Demax Medical Technology Co.,Ltd · 2023
  • K222182Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd · 2023
  • K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015

All 4 as Beijing Demax Medical Technology Co.,Ltd →