510(k) Report

FDA applicant

Hangzhou Bever Medical Devices Co., Ltd.

Hangzhou, Zhejiang, CN4 decisions2012–20191 recall

FDA records 4 decisions for Hangzhou Bever Medical Devices Co., Ltd. (Hangzhou, Zhejiang, CN) from 2012 to 2019: 4 510(k) clearances. Most are in product codes GBM (Catheter, Urethral) and BTR (Tube, Tracheal (W/Wo Connector)). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Hangzhou Bever Medical Devices Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012: 32019: 1
2012high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2012high 1 (2025) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Hangzhou Bever Medical Devices Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hangzhou Bever Medical Devices Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GBMCatheter, Urethral2decisions
  • BTRTube, Tracheal (W/Wo Connector)2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 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.

  • K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 20123cite it
  • K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,Hangzhou Bever Medical Devices Co., Ltd. · 20122cite it
  • K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal Tube Without Cuff…Hangzhou Bever Medical Devices Co., Ltd. · 20121cites it
  • K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter…Hangzhou Bever Medical Devices Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter…Hangzhou Bever Medical Devices Co., Ltd. · 20191 recall
  • K111406Bever Reinforced Endotracheal Tube with Cuff (Oral/Nasal), Bever Reinforced Endotracheal Tube Without Cuff…Hangzhou Bever Medical Devices Co., Ltd. · 2012
  • K111401Bever Endotracheal Tube, Bever Eva Endotracheal TubeHangzhou Bever Medical Devices Co., Ltd. · 2012
  • K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter,Hangzhou Bever Medical Devices Co., Ltd. · 2012

All 4 as Hangzhou Bever Medical Devices Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192468BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF…Nov 29, 2025Class II