# K221598: Wearable breast pump

- Pathway: 510(k) (Traditional)
- Applicant: Mayborn (Uk) Limited
- Decided: Dec 9, 2022 after 190 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: 7 generations back to K801862 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181863: Elvie Pump, Chiaro Technology Limited (2018) Summary page 4.

## Indications for use
The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Source page: https://510kreport.com/device/K221598
Methodology: https://510kreport.com/methodology