# K141742: Ardo Carum and Calypso Powered Breast Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Ardo Medical AG
- Decided: Oct 17, 2014 after 112 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: 2 generations back to K801862 (1980). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020518: Medela Symphony Breast Pump, Model 024, Medela, Inc. (2002) Summary page 4.

## Most influential descendants
- K172067: One Mum Pumpset (2017), 0 descendants of its own
- K163183: Yooeehouse Breast Pump (2017), 0 descendants of its own
- K150721: ARDO Calypso Pro Powered Breast Pump (2015), 0 descendants of its own

## Indications for use
The ARDO Carum powered 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. The ARDO Calypso 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 single users. The ARDO Pumpset should be used in combination with ARDO breast pumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset.

Source page: https://510kreport.com/device/K141742
Methodology: https://510kreport.com/methodology