# K230280: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: May 11, 2023 after 99 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 4.

## Indications for use
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure. The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

Source page: https://510kreport.com/device/K230280
Methodology: https://510kreport.com/methodology