510(k) Report

FDA applicant

Besmed Health Business Corp

New Taipei City, TW11 decisions2003–20241 recall

FDA records 11 decisions for Besmed Health Business Corp (New Taipei City, TW) from 2003 to 2024: 11 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BWF (Spirometer, Therapeutic (Incentive)). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Besmed Health Business Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Besmed Health Business Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12014: 32015: 22016: 12018: 12024: 1
2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Besmed Health Business Corp by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Besmed Health Business Corp’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?

  • CAFNebulizer (Direct Patient Interface)2decisions
  • BWFSpirometer, Therapeutic (Incentive)2decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • BYEAttachment, Breathing, Positive End Expiratory Pressure1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • CAHFilter, Bacterial, Breathing-Circuit1decision

Also: IPF (1), CAP (1), BZH (1).

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 4 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.

  • K133873Triball Incentive SpirometerBesmed Health Business Corp · 20142cite it
  • K091272Besmed Jet Nebulizer Bottle SetBesmed Health Business Corp · 20091cites it
  • K141355Volumetric Incentive SpirometerBesmed Health Business Corporation · 20141cites it

What has FDA decided for it lately?

  • K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
  • K172804Besmed Peak Flow MeterBesmed Health Business Corp · 2018
  • K160112Besmed PEEP ValveBesmed Health Business Corp · 2016
  • K150591Besmed Reusable Jet NebulizerBesmed Health Business Corp · 2015
  • K143150CO2 monitoring line with and without in-line filterBesmed Health Business Corp · 2015
  • K141355Volumetric Incentive SpirometerBesmed Health Business Corporation · 2014
  • K140370Disposable Pressure ManometerBesmed Health Business Corp · 2014
  • K133873Triball Incentive SpirometerBesmed Health Business Corp · 2014

All 10 as Besmed Health Business Corp →The one decision as Besmed Health Business Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091272Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor…Aug 29, 2018Class II