510(k) Report

FDA applicant

Yunyi (Beijing) Medical Device Co., Ltd.

Beijing, CN2 decisions2020–20210 recalls

FDA records 2 decisions for Yunyi (Beijing) Medical Device Co., Ltd. (Beijing, CN) from 2020 to 2021: 2 510(k) clearances. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2021

2020: 12021: 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 — Yunyi (Beijing) Medical Device Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yunyi (Beijing) Medical Device 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?

  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd. · 2021
  • K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd. · 2020

All 2 as Yunyi (Beijing) Medical Device Co., Ltd. →