510(k) Report

FDA applicant

Bh Medical Products Co., Ltd.

Changzhou, CN3 decisions2015–20190 recalls

FDA records 3 decisions for Bh Medical Products Co., Ltd. (Changzhou, CN) from 2015 to 2019: 3 510(k) clearances. Most are in product codes PEM (Dental Barriers And Sleeves) and FXX (Mask, Surgical). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2019

2015: 12018: 12019: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Bh Medical Products 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?

  • PEMDental Barriers And Sleeves1decision
  • FXXMask, Surgical1decision
  • FRGWrap, Sterilization1decision

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 13 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.

  • K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 20159cite it
  • K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 20193cite it
  • K172280BH Sterilization PouchBh Medical Products Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. · 2019
  • K172280BH Sterilization PouchBh Medical Products Co., Ltd. · 2018
  • K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015

All 3 as Bh Medical Products Co., Ltd. →