510(k) Report

FDA applicant

Beijing Keyi Medical Device Technology Co., Ltd.

Beijing, CN4 decisions2017–20240 recalls

FDA records 4 decisions for Beijing Keyi Medical Device Technology Co., Ltd. (Beijing, CN) from 2017 to 2024: 4 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 281 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 12 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2024

2017: 12019: 12020: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Beijing Keyi Medical Device Technology Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beijing Keyi Medical Device Technology…’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?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision
  • HRSPlate, Fixation, Bone1decision
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 281 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2024
  • K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2020
  • K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2019
  • K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd. · 2017

All 4 as Beijing Keyi Medical Device Technology Co., Ltd. →