510(k) Report

FDA applicant

Vincent Healthcare Products Limited

Hung Hom, HK2 decisions2022–20260 recalls

FDA records 2 decisions for Vincent Healthcare Products Limited (Hung Hom, HK) from 2022 to 2026: 2 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and BZE (Heater, Breathing System W/Wo Controller (Not…). 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, anesthesiology panel, where it files most

How often FDA has decided Vincent Healthcare Products Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Vincent Healthcare Products Limited by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision
  • BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™…Vincent Healthcare Products Limited · 2026
  • K222351inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited · 2022

All 2 as Vincent Healthcare Products Limited →