510(k) Report

FDA applicant

B&J Manufacturing, Ltd.

Shenzhen, CN4 decisions2020–20200 recalls

FDA records 4 decisions for B&J Manufacturing, Ltd. (Shenzhen, CN) in 2020: 4 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 4 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, cardiovascular panel, where it files most

How often FDA has decided B&J Manufacturing, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2020

2020: 4
2020high 4 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — B&J Manufacturing, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like B&J Manufacturing, 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?

  • JOWSleeve, Limb, Compressible4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 116 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 158 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K201532B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing, Ltd. · 20201cites it
  • K201547B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 20201cites it
  • K200154B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd. · 20201cites it

What has FDA decided for it lately?

  • K201532B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing, Ltd. · 2020
  • K201547B&J DVT Foot Garments, Models 820 SeriesB&J Manufacturing, Ltd. · 2020
  • K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing, Ltd. · 2020
  • K200154B&J DVT Compression Devices MHH800/MHH800SQB&J Manufacturing, Ltd. · 2020

All 4 as B&J Manufacturing, Ltd. →