510(k) Report

FDA applicant

Bq Plus Medical Co., Ltd.

Shanghai, CN3 decisions2021–20241 recall

FDA records 3 decisions for Bq Plus Medical Co., Ltd. (Shanghai, CN) from 2021 to 2024: 3 510(k) clearances. All are in product code FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 244 for FDA’s reviews in the same codes and years. Its devices cite 2 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2024

2021: 12023: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2021high 1 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Bq Plus Medical Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bq Plus 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.

See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 163 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 244 days; 2 of its 3 were faster than that.

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?

  • K242126I.V. Administration SetBq Plus Medical Co., Ltd. · 20241 recall
  • K223645I.V. Administration Set, I.V. Extension SetBq Plus Medical Co., Ltd. · 2023
  • K210381I.V. Administration SetBq Plus Medical Co., Ltd. · 2021

All 3 as Bq Plus Medical Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K242126Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN…Dec 31, 2025Class II