510(k) Report

FDA applicant

Beijing Kreate Medical Co., Ltd.

Beijing, CN3 decisions2026–20260 recalls

FDA records 3 decisions for Beijing Kreate Medical Co., Ltd. (Beijing, CN) in 2026: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and QSZ (Absorbable Synthetic Wound Dressing). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 254 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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

How often FDA has decided Beijing Kreate Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2026

2026 (partial year): 3
2026high 3 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Beijing Kreate Medical 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?

  • FRODressing, Wound, Drug2decisions
  • QSZAbsorbable Synthetic Wound Dressing1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 101 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 254 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 20261cites it

What has FDA decided for it lately?

  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026

All 3 as Beijing Kreate Medical Co., Ltd. →