# K172067: One Mum Pumpset

- Pathway: 510(k) (Special)
- Applicant: Ardo Medical AG
- Decided: Nov 29, 2017 after 145 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 One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.

Source page: https://510kreport.com/device/K172067
Methodology: https://510kreport.com/methodology