# K173699: The Pump by Babyation

- Pathway: 510(k) (Traditional)
- Applicant: Babyation, LLC
- Decided: Apr 4, 2018 after 121 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: 4 generations back to K801862 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160511: Naya Breast Pump System, Naya Health, Inc. (2016) Summary page 4.

## Indications for use
The Pump by Babyation is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts. The Pump by Babyation can be used by multiple users.

Source page: https://510kreport.com/device/K173699
Methodology: https://510kreport.com/methodology