# K101157: E-Basic Single Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mapa GmbH
- Decided: Sep 17, 2010 after 144 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: 1 generation back to K082802 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082802: Mipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery Breast Pump & Mipump Deluxe Double Electric/B, Learning Curve Brands Inc. the First Years (2008) Summary page 2.

## Indications for use
The NUK® Easy-Flow Tm Single Electric Breast Pump is intended for use to express milk from the breast by a single user.

Source page: https://510kreport.com/device/K101157
Methodology: https://510kreport.com/methodology