510(k) Report

FDA applicant

Belun Technology Company Limited

Sha Tin, HK5 decisions2018–20240 recalls

FDA records 5 decisions for Belun Technology Company Limited (Sha Tin, HK) from 2018 to 2024: 5 510(k) clearances. Most are in product codes DQA (Oximeter) and MNR (Ventilatory Effort Recorder). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 183 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Belun Technology Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 12021: 12023: 12024: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Belun Technology Company Limited by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Belun Technology Company Limited’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?

  • DQAOximeter4decisions
  • MNRVentilatory Effort Recorder1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 168 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 183 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K211407Belun Ring BLR-100XBelun Technology Company Limited · 20212cite it
  • K180174Belun RingBelun Technology Company Limited · 20181cites it
  • K191417Belun RingBelun Technology Company Limited · 20191cites it

What has FDA decided for it lately?

  • K234110Belun Ring BLR-200 (BLR-200)Belun Technology Company Limited · 2024
  • K222579Belun Sleep System BLS-100Belun Technology Company Limited · 2023
  • K211407Belun Ring BLR-100XBelun Technology Company Limited · 2021
  • K191417Belun RingBelun Technology Company Limited · 2019
  • K180174Belun RingBelun Technology Company Limited · 2018

All 5 as Belun Technology Company Limited →