510(k) Report

FDA applicant

Ga Health Company Limited

Hong Kong, CN12 decisions2020–20230 recalls

FDA records 12 decisions for Ga Health Company Limited (Hong Kong, CN) from 2020 to 2023: 12 510(k) clearances. Most are in product codes OCX (Endoscopic Irrigation/Suction System) and ODC (Endoscope Channel Accessory). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 4 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, gastroenterology and urology panel, where it files most

How often FDA has decided Ga Health Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

4in 2023

2020: 52021: 12022: 22023: 4
2020high 5 (2020) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ga Health Company Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ga Health 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?

  • OCXEndoscopic Irrigation/Suction System6decisions
  • ODCEndoscope Channel Accessory4decisions
  • KTIBronchoscope Accessory1decision
  • OCUEndoscopic Storage Cover1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 109 days; 10 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K202560AquaPulse Irrigation TubingGa Health Company Limited · 20202cite it
  • K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited · 20201cites it
  • K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited · 20201cites it
  • K200479AquaPulse Auxiliary Water ConnectorGa Health Company Limited · 20201cites it

What has FDA decided for it lately?

  • K232118ANDORATE® Valve KitGa Health Company Limited · 2023
  • K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingGa Health Company Limited · 2023
  • K230932ANDORATE® Valve KitGa Health Company Limited · 2023
  • K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited · 2023
  • K223171AquaPulse® Irrigation TubingGa Health Company Limited · 2022
  • K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited · 2022
  • K202838Andorate Universal Endoscope Tip GuardGa Health Company Limited · 2021
  • K202560AquaPulse Irrigation TubingGa Health Company Limited · 2020

All 12 as Ga Health Company Limited →