# K230590: ARDO Bellis

- Pathway: 510(k) (Special)
- Applicant: Ardo Medical AG
- Decided: Mar 30, 2023 after 27 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801862 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212773: ARDO Alyssa, Ardo Medical AG (2022) Summary page 4.

## Indications for use
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.

Source page: https://510kreport.com/device/K230590
Methodology: https://510kreport.com/methodology