# K230481: Evenflo Premium Double Electric Breast Pump (Model 4018)

- Pathway: 510(k) (Traditional)
- Applicant: Evenflo Feeding, Inc.
- Decided: Nov 3, 2023 after 254 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 K875300 (1988). 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)
- K131153: Evenflo Advanced Double Electric Breast Pump, Evenflo Feeding Incorporated (2013) Summary page 4.

## Indications for use
The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman’s breasts. It is intended for a single user.

Source page: https://510kreport.com/device/K230481
Methodology: https://510kreport.com/methodology