Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ga Health Company Limited · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

97 daysmedian FDA review time
117 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232118ANDORATE® Valve KitGa Health Company Limited2023-10-16910
K231602Protego Air Water Connector; Protego Air Water Bottle TubingGa Health Company Limited2023-08-01610
K230932ANDORATE® Valve KitGa Health Company Limited2023-07-07950
K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveGa Health Company Limited2023-05-11990
K223171AquaPulse® Irrigation TubingGa Health Company Limited2022-11-10300
K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited2022-01-121100
K202838Andorate Universal Endoscope Tip GuardGa Health Company Limited2021-03-051610
K202560AquaPulse Irrigation TubingGa Health Company Limited2020-12-10970
K200495Andorate Disposable Air/Water Valve, Andorate Disposable SucGa Health Company Limited2020-06-241170
K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited2020-06-181120
K200479AquaPulse Auxiliary Water ConnectorGa Health Company Limited2020-05-15780
K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with LGa Health Company Limited2020-04-14560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda