# K150721: ARDO Calypso Pro Powered Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Ardo Medical AG
- Decided: Jun 17, 2015 after 90 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: 3 generations back to K801862 (1980). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141742: Ardo Carum and Calypso Powered Breast Pumps, Ardo Medical AG (2014) Summary page 4.

## Indications for use
The ARDO Calypso Pro breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.

Source page: https://510kreport.com/device/K150721
Methodology: https://510kreport.com/methodology